.

Careers

Senseonics is committed to a working environment where individuals can thrive in a creative, challenging and professional environment. At the heart of what we do is our dedication to our customers – people with diabetes, their families and their caregivers – who trust our products to become integral parts of their lives. We are a dynamic, advanced, results-oriented team focused on making innovative and technically superior products.

Principal Embedded Software Engineer

04/18/2017

About the Position

The Principal Embedded Software Engineer position will be involved in many different aspects of the product life-cycle, ranging from product architecture and definition through software design and validation.
Candidate will be a key member of the engineering team developing embedded software for real time control of inertial measurement hardware and the solution of complex navigation algorithms.
Works with cross functional technical engineering team to ensure that software requirements are fully understood and implemented.
This is a senior level technical position, responsible for developing concepts and solutions to complex issues, performing trade studies, and overseeing development activities through integration into production.

Responsibilities include:

  • Design and implement software of embedded devices and systems from requirements to production and commercial deployment.
  • Design, develop, code, test and debug system software.
  • Review code and design.
  • Analyze and enhance efficiency, stability and scalability of system resources
  • Integrate and validate new product designs.
  • Support software QA and optimize I/O performance.
  • Provide post production support.
  • Interface with hardware design and development.
  • Writing relevant design and test documentation, validation and release.

Requirements include:

  • 15+years of experience in embedded software engineering
  • BS or higher degree in Computer Science, Computer Engineering , Electrical Engineering or related field.
  • Experience in hands-on development and troubleshooting on embedded targets.
  • Proficient developing projects on resource-constrained, embedded systems.
  • Strong knowledge of power managements, memory management, security, and industry safety.
  • Experience with wired and wireless communication protocols; USB, TCP/IP, Bluetooth, Wi-Fi etc.
  • Hands-on system bring-up, testing, and troubleshooting on embedded targets
  • Experience using RTOS’s and related stacks, time-critical, and interrupt-based design
  • Experience in developing BSPs for embedded systems using MCUs and MPUs
  • Adequate knowledge of reading schematics and data sheets for components
  • Familiarity with software configuration management tools, defect tracking tools, and peer review
  •  

    Senseonics is an Equal Opportunity Employer and does not discriminate based on race, religion, gender, national origin, color, age, military service eligibility or veteran status, disability, sexual orientation, marital status or any other protected class. We offer competitive salaries and benefits, for consideration, please submit your resume electronically to HR@senseonics.com.

Director of Market Access

04/12/2017

About the Position

We are looking for a Director of Market Access that will develop and implement market access and reimbursement strategies assuring that commercial and national payer coverage, coding and payment policies support the commercial position of Senseonics products.

Responsibilities include:

  • Develop strategies and tactics to secure and maintain access of the Eversense® CGM system.
  • Develop breadth of payer communication tools to support sales and marketing in payer negotiations to ensure positive outcome for Senseonics.
  • Develop breadth of provider communication tools to support provider access and payment to Eversense product.
  • Optimize access and reimbursement to the Eversense product by pro-actively engaging with payers to assure a favorable coverage and policy environment.
  • Maintain database of payer coverage policies including scheduled review and meeting dates.
  • Coordinate the cross-functional efforts with sales, marketing and finance to support the access planning process, including the situation analysis, creation of access strategies, identification of critical success factors, development of pricing guidance and policy, as well as the execution of these plans/strategies.
  • Manage pricing & access assumptions in revenue forecasts.
  • Conduct relevant payer/pricing market research and integrate clinical, market and payer information to develop and communicate the access plan.
  • Support account planning in coordination with sales for key National Accounts.
  • Provide interpretive guidance regarding market intelligence and proposed solutions as to the impact of potential access/reimbursement issues, and competitive contracting information.
  • Works closely with sales organization and providers to problem solve denials and delayed patient starts.
  • Assists in the development of brand strategies and business plans to ensure a consistent brand objective.
  • Provide content and expertise during strategic planning process regarding customer needs and insights surrounding access and reimbursement.

Requirements include:

  • Bachelor's degree; master's degree preferred
  • Minimum of seven (7) years’ experience medical devices. National Account experience preferred.
  • Strong understanding of the payer environment, including coverage and reimbursement, pricing, health technology assessment, and health care policy.
  • Experience with commercial or payer assessments for early stage pipeline programs
  • Ability to review clinical and health economic literature, including disease state information, clinical trial design and results in order to understand implications for value to payers.
  • Ability to conduct situation analysis of external pricing and reimbursement environment and synthesize relevant information to develop strategic plans
  • Ability to develop and test value messages and value evidence with payers in order to determine the most compelling way in which to demonstrate and communicate product value to payers
  • Ability to formulate health policy strategy and implement these strategies to shape external pricing and reimbursement environment
  • Demonstrated ability to think and plan strategically, identify strategic options and trade-offs Strong analytical skills
  • Demonstrated ability in development of business strategy
  • Demonstrated ability to work effectively with cross functional teams to gain alignment and improve business performance.
  • Demonstrated success as a team leader with strong team management skills.
  • Excellent oral/written communications skills and interpersonal skills.
  •  

    Senseonics is an Equal Opportunity Employer and does not discriminate based on race, religion, gender, national origin, color, age, military service eligibility or veteran status, disability, sexual orientation, marital status or any other protected class. We offer competitive salaries and benefits, for consideration, please submit your resume electronically to HR@senseonics.com.

Supply Chain Manager

04/11/2017

About the Position

Manages supply chain systems and direct daily operations. Performs logistics support tasks within supply chain element area(s) (ILS planning, maintenance planning, supply support, test and support equipment, packaging/handling/storage/ transportation, personnel and training, data. computer resources, design interface) for systems, subsystems, and equipment. Perform analyses, studies, problem identification and resolution in support of a customer logistics area manager.

Responsibilities include:

  • Implement new or improved supply chain processes.
  • Monitor forecasts and quotas to identify changes or to determine their effect on supply chain activities.
  • Monitor supplier performance to assess ability to meet quality and delivery requirements.
  • Maintains metrics, reports, process documentation, or customer service logs.
  • Document physical supply chain processes, such as workflows, cycle times, position responsibilities, or system flows.
  • Resolves problems relating to transportation, logistics systems, imports or exports, and customer issues.
  • Assess contract manufacturers’ material handling processes and their efficiency for handling Senseonics inventory.
  • Appraise vendor manufacturing ability through on-site visits and measurements.
  • Review or update supply chain practices in accordance with new or changing environmental policies, standards, regulations, or laws.
  • Negotiate prices and terms with suppliers, vendors, or freight forwarders.
  • Work with internal stakeholders to develop suitable supply chain information systems globally.
  • Collaborate with other departments to identify or qualify new suppliers.
  • Participate in the coordination of engineering changes, product line extensions, or new product launches to ensure orderly and timely transitions in material or production flow.

*The company reserves the right to add or change duties at any time.

Requirements include:

  • Education: Bachelor’s degree in business, supply chain management, or a related field
  • Experience: 3-5 years of related experience

Skills:

  • Excellent oral and written communication skills
  • Time management
  • Active listening
  • Complex problem solving
  • Critical thinking
  • Judgment and decision making
  •  

    Senseonics is an Equal Opportunity Employer and does not discriminate based on race, religion, gender, national origin, color, age, military service eligibility or veteran status, disability, sexual orientation, marital status or any other protected class. We offer competitive salaries and benefits, for consideration, please submit your resume electronically to HR@senseonics.com.

Product Manager

04/06/2017

About the Position

We are seeking an experienced Product Manager who is passionate about developing products that make a difference in the lives of people with diabetes.  The position is located in Germantown, Maryland.  The successful candidate will be responsible for engaging with all functional areas of the organization, as well as customer segments, to ensure product design meets the needs of users, exceeds their expectations when possible, provides competitive advantages for the business, and adheres to required regulatory and quality standards

Responsibilities include:

  • Provide design inputs to engineering team for products in development
  • Gather market research from internal and external customer segments
  • Understand in great detail competitive offerings in a rapidly changing industry
  • Manage Assistant Product Manager and other staff as applicable
  • Drive the development and manage revision control of labeling documents with patients and healthcare professionals as the audience for submissions to various regulatory bodies
  • Collaborate on creating and delivering product positioning for new product offerings, working closely with Marketing team to ensure consistent messaging across the product portfolio
  • Project manage and execute integrated pre-launch campaigns, working with Customer Support, Engineering, Clinical and Quality teams
  • Liaise with third party partners to develop and maintain compatibility between systems
  • Develop and deliver product training and sales training programs for internal and external audiences
  • Support Sr. Marketing Manager in portfolio management, business development and other strategic activities

Requirements include:

  • Highly project-oriented and able to manage multiple complex projects
  • Positive mindset, detail-oriented, with excellent tactical skills
  • Exceptional communications, motivational and influencing talents
  • Outstanding English writing skills, to ensure customer-facing documents are grammatically correct
  • 5-7 years of product management experience in the medical device industry; insulin pumps and/or continuous glucose monitoring strongly preferred
  • Ability to work successfully as an individual contributor, leader, and a team member
  • Strong problem resolution skills required, with staunch commitment to persevere in the face of change
  • MS/BS degree in Marketing, Design, Communications or equivalent experience preferred
  • Willing to travel domestically and/or internationally ~25% of the time

Senseonics is an Equal Opportunity Employer and does not discriminate based on race, religion, gender, national origin, color, age, military service eligibility or veteran status, disability, sexual orientation, marital status or any other protected class. We offer competitive salaries and benefits, for consideration, please submit your resume electronically to HR@senseonics.com.

Marketing Communications Manager

04/05/2017

About the Position

We are seeking an experienced Marketing Communications Manager who is passionate about developing products that make a difference in the lives of people with diabetes. 

Responsibilities include:

  • Manage internal and external communications
  • Principle liaison to PR company
  • Develop and manage website roadmap
  • Collaborate with marketing team to develop digital media strategy
  • Create and implement communications plan for website and other customer inquiries
  • Responsible for vendor management of website and content management
  • Assist with the creation and production of marketing materials and literature for different customer segments
  • Ensure appropriate revision control of documents is maintained
  • Liaise with distributor partners in multiple countries to support launch activities for multiple products
  • Provide support for marketing events and exhibits in the US and abroad
  • Assist in product launch activities by working with Customer Service, Engineering and Clinical teams
  • Liaise with external agencies for PR, artwork and content creation of sales, marketing and packaging materials

Requirements include:

  • Capable of working on multiple complex projects simultaneously
  • Able to handle rapidly shifting priorities with positive attitude
  • Detail-oriented, with excellent tactical skills
  • Excellent English writing skills, to ensure customer-facing documents are grammatically correct
  • Prior experience with creative, communication or design agencies required; medical device industry/diabetes focus strongly preferred
  • Ability to work with little supervision and effectively as a team member
  • MS/BS degree in Marketing, Design, Communications or equivalent experience preferred
  • Ability to travel domestically and/or internationally ~25% of the time

Senseonics is an Equal Opportunity Employer and does not discriminate based on race, religion, gender, national origin, color, age, military service eligibility or veteran status, disability, sexual orientation, marital status or any other protected class. We offer competitive salaries and benefits, for consideration, please submit your resume electronically to HR@senseonics.com.

Senior Accountant

04/05/2017

About the Position

We are looking for a full time Senior Accountant to support the finance team with all aspects of the day to day accounting function as needed. The ideal candidate is ready to work hard, have fun, and utilize their technical skills to further develop their accounting career.

This is an excellent opportunity where you will gain valuable experience and have impact in multiple facets of operational accounting and related tasks in a publicly traded, dynamic, and rapidly growing business. 

Responsibilities include:

  • Support the preparation and analysis of monthly and quarterly results
  • Assist with annual and quarterly audits
  • Identify, suggest, and adhere to internal control policies and procedures
  • Perform inventory and cost accounting reconciliations and analysis
  • Maintain accurate inventory and cost accounting records in the MRP system
  • Help expand and maintain ERP system
  • Perform account reconciliations and close procedures
  • Record and review accounting transactions following Senseonics internal control processes
  • Provide assistance for special accounting projects as needed

Requirements include:

  • Minimum 2+ years of accounting experience
  • Bachelor’s degree or equivalent in Accounting required
  • CPA license a plus
  • Interest in accounting function of a publicly traded company
  • Analytical skills and a sound understanding of accounting principals
  • Ability to demonstrate attention to detail and effective record keeping
  • Ability to work well under pressure and prioritize work to meet challenging deadlines
  • Excellent written and oral communication and a positive, team-oriented attitude

Mechanical Engineering Internship

03/21/2017

About the Position

We are looking for an outstanding and highly motivated intern for a paid part-time role on our Mechanical Engineering team.  The intern will be working with experienced engineers and will be a part of a team that is delivering the latest Senseonics flagship products.  This opportunity will allow the intern to learn the technical skills that go into building a medical device, product development life cycle, and professional skills critical to producing exceptional work under the guidance of a Principal Mechanical Engineer.

Responsibilities include:

  • Apply basic Mechanical Engineering principles, theories and concepts to drafting, modeling, testing, and documenting product features and functions.
  • Assist the design team to build and automate production equipment and fixtures.
  • Prototype and present design concepts
  • Perform other duties as assigned

Requirements Include:

  • Applicants must have completed their junior year at an accredited college or university in Mechanical Engineering or equivalent. 
  • Minimum GPA requirement:  Cumulative 3.0
  • Basic familiarity with common electronic devices
  • Creativity, ability for independent thinking and drive to work on challenging problems
  • Strong verbal and written communication skills
  • Highly organized, ability to prioritize with attention to detail
  • Ability to meet deadlines
  • Minimum classes: statics, mechanics of materials, dynamics, engineering design is a plus
  • SolidWorks experience is a plus
  • Matlab experience is a plus
  • Candidates must be eligible to legally work in the US

Document Control Specialist

03/07/2017

About the Position

We are looking for a talented Document Control Specialist to help us continue producing quality output. The Document Control Specialist is responsible for administering and maintaining a comprehensive ISO 13485/QSR compliant document/change control system and training system. Documents will include but are not limited to all controlled documents i.e. quality records, procedures and specifications. The position requires a candidate with two year college degree or higher. At least two (2) years of direct responsibility in document control is required.

Responsibilities include:

  • Maintain a computer database (MasterControl) of all filed documentation that ensures fast retrieval of documents.
  • Support the configuration and implementation a comprehensive document control system that functions effectively in a fast-paced, small company environment.
  • Provide document control support for Microsoft Word, Excel and pdf files
  • Create, maintain document and form templates
  • Route training for all employees when there is a change in any quality procedure / work instructions.
  • Coordinate New Employee Orientation Training.
  • Work directly with Quality Team for file migrations and audits, and perform administrative tasks as needed.
  • Maintain supplier files and certifications up to date
  • Prepare and execute the Computer Software Tool Validation (OQ, PQ) Test Scripts

Requirements Include:

  • Two (2) year college degree or higher required
  • 2+ years of experience as a document control specialist.
  • Minimum 1 year of experience in MasterControl System.
  • Experience in ClearQuest Tool and Tool Validation is a plus.
  • Medical Device Regulated work experience is a plus.

Senseonics is an Equal Opportunity Employer and does not discriminate based on race, religion, gender, national origin, color, age, military service eligibility or veteran status, disability, sexual orientation, marital status or any other protected class. We offer competitive salaries and benefits, for consideration, please submit your resume electronically to HR@senseonics.com.

Senior Regulatory Affairs Specialist

03/09/2017

Job Summary

Senior Regulatory Affairs Specialist will prepare, review, and submit documents for global product approvals. These documents include Investigational Device Exemption applications, Premarket Approval applications, Technical Files, amendments, and appropriate follow-up responses and reports. This position works with program teams to identify regulatory requirements early in the new product development process.

Duties and Responsibilities include but are not limited to:

  • Write submission documents for FDA, Health Canada, Notified Bodies, and other regulatory agencies. Develop responses to questions or deficiency letters from regulatory agencies.
  • Proactively partner with R&D, Marketing and other groups to confirm the regulatory requirements necessary to place products on international and domestic markets. Develop and approve appropriate technical documents for regulatory submissions in support of the development project.
  • Develop and maintain Technical Files for CE marking.
  • Assess regulatory impact of post-market changes on labeling, design, materials, manufacturing process, sterilization or packaging.
  • Participate as a member of new product development teams to provide regulatory support to the project.
  • Identify and implement process improvements and updates to regulatory department SOPs.
  • Review new regulations for implications for the company and recommend strategy to achieve compliance with requirements.
  • Participate in ensuring a global regulatory team approach.

Knowledge, Skills, Abilities and Requirements:

  • Required 3-4 years in regulatory affairs within the medical device industry
  • Preferred experience in FDA submissions
  • Preferred experience in writing/maintaining CE Technical Files
  • Minimum Bachelor’s degree in a technical discipline required, Master's Degree in a technical discipline preferred

Senior Software Test Engineer

03/07/2017

About the Position

We are looking for a talented Senior Software Test Engineer to help us continue producing quality output. The Senior Software Test Engineer is responsible for developing and executing the test scripts, based on functional requirements, and use cases provided by the business. The individual will work collaboratively with Product Development and Offshore Test Teams, and will apply Quality Assurance methodologies and processes to make sure deliverables meet company's highest standards. The position requires a candidate with Masters in Computer Engineering or related field, with 5 years of medical device software testing experience or a Bachelors degree in these fields with 7+ years of experience.

Responsibilities include:

  • Review software requirements to ensure that requirements stated are correct, unambiguous, and verifiable.
  • Consult with product development to evaluate system interfaces, operational requirements, and performance requirements of software components in the overall system.
  • Manage the testing activities and traceability per IEC 62304.
  • Define test methods and create test plans for new or updated software projects to determine the software design accuracy according to documented requirements as well as established standards.
  • Recommend design improvements or corrections throughout the development process.
  • Maintain effective communication with the project software engineers on project limitation, capability, performance requirement and hardware interface changes.
  • Execute test plans and create test reports to describe test execution summary and deviations.
  • Facilitate the software defect risks per ISO 14971
  • Coordinate with Offshore team for testing activities

Requirements include:

  • Minimum of 5 years of experience in medical device software testing, preferably in embedded, mobile and cloud server applications.
  • Experienced in IEC 62304 standard within a medical product development environment
  • Experienced in Good Documentation and Testing Practices
  • Excellent Test script writing skills
  • Knowledge on ISO 14971 standard
  • Minimum Bachelors in Computer Engineering or equivalent, advanced degree (Masters) preferred

Senseonics is an Equal Opportunity Employer and does not discriminate based on race, religion, gender, national origin, color, age, military service eligibility or veteran status, disability, sexual orientation, marital status or any other protected class. We offer competitive salaries and benefits, for consideration, please submit your resume electronically to HR@senseonics.com.

Automation Engineer

12/23/2016

About the Position

We are looking for a full time automation engineer to develop new processes for treatment and functionalization of sensors in the medical device area  activities for Senseonics. The engineer will work with chemists, chemical engineers, electronics engineers, mechanical engineers and medical device experts to scale up inventions and designs from the lab. This position will be responsible for the automation of the processes.

This role will be part of a larger multi-disciplinary process design and development group. Success requires the applicant should be able to learn new areas of technology and be willing to dive into new problems as they arise. The candidate needs to show their experience in similar situations.

The position requires a candidate with MS or PhD in Mechanical Engineering, Electronics, Robotics, Industrial engineering, Process Control or related field with 3+ years experience in the industry or a Bachelors degree in these fields with 7+ years of experience.

Responsibilities include:

  • Will work with process design team to build robotics and automate the process of chemical treatment of the sensor
  • Needs to understand statistics to design robust processes
  • Will understand and implement control, design tests for product specifications and performance of processes designed
  • Will ensure processes are consistent with cGMP and will work with regulatory and quality groups to ensure compliance

Requirements include:

  • Experience with Robotics, automation and control, design, 
  • 3+ years experience in design and implementation of automation technology in the industry. Exposure to cGMP or other quality management systems. Experience with lean sigma, six sigma or other process management techniques a plus
  • Experience working with or qualifying vendors and contract manufacturers

Senseonics is an Equal Opportunity Employer and does not discriminate based on race, religion, gender, national origin, color, age, military service eligibility or veteran status, disability, sexual orientation, marital status or any other protected class. We offer competitive salaries and benefits, for consideration, please submit your resume electronically to HR@senseonics.com.

Customer Support Professional

12/23/2016

About the Position

We are looking for a full-time Customer Support Professional to provide product support services for the Eversense Continuous Glucose Monitoring System to Senseonics’ worldwide customers; distributors, consumers, physicians and facilities.

Responsibilities include:

  • Provides expert level support for the Eversense CGM system; Sensor, App, Transmitter and DMS.
  • Ensures a very positive customer experience for users of the Eversense CGM system; facilitates resolution of issues and concerns via coordination with distributor Customer Support and field-based teams as necessary.
  • Coverage for Eversense Customer Support contacts received via email, phone, and web as required.
  • Maintains current process information for distributor locations by country.
  • Documentation of all contacts in ERP database and other systems.
  • Oversees distributor follow up on open issues and cases.
  • Works closely with Level 3 support to identify and resolve unique user issues.
  • Generates and communicates Return Authorization numbers for distributor product return handling.
  • Other responsibilities as markets expand.

EDUCATION/EXPERIENCE:

  • BA, BS in Life Sciences preferred.
  • Experience in the diabetes industry preferred.
  • Minimum of five years’ experience providing medical device, medical procedure, therapy or pharmaceutical support to healthcare professionals, providers and consumers.
  • Working knowledge of HIPAA regulations.
  • Experience in disease state management, co-morbidities.
  • Proficient with cellular technology iOS and Android
  • Knowledge of FDA’s Quality System Regulations.
  • Excellent oral and written communication skills.
  • Proficient Micro Soft Office
  • Knowledge of FDA Quality System Regulations.

SKILLS

  • Excellent communication skills; verbal and written. Must be able communicate effectively and in a collaborative manner with all internal and external associates on the phone and through web-based communications.
  • Experienced with SalesForce or similar CRM, ERP and complaint handling systems.
  • Bi-lingual a plus.

Senseonics is an Equal Opportunity Employer and does not discriminate based on race, religion, gender, national origin, color, age, military service eligibility or veteran status, disability, sexual orientation, marital status or any other protected class. We offer competitive salaries and benefits, for consideration, please submit your resume electronically to HR@senseonics.com.

Director of Quality and Regulatory

02/01/2017

About the Position

We are looking for a full time Director of Quality and Regulatory Sciences that is innovative and willing to cover all aspects of the quality and regulatory systems of the company. The Quality/Regulatory Director is responsible for Senseonics quality and regulatory strategic direction, managing the Quality Management System, communicating with FDA and European regulatory agencies, and implementing all requirements to maintain compliance.  Candidate must have strong analytical, statistical, database and spreadsheet skills with excellent written and oral communication skills, a Can-Do-Attitude and a willingness to learn. The position requires limited domestic and International travel (10-20%) for supplier audits. 

Responsibilities include:

  • Develop and implement regulatory strategies in support of new product development 
  • Lead the company’s discussions with all external regulatory agencies 
  • Manage the day to day execution of quality systems and implements improvements to the quality system while maintaining compliance with applicable Quality System Regulations and ISO standards (13485 and QSR) 
  • Lead and participate in audits (external and internal) 
  • Interface with contract manufacturing and other critical suppliers; conduct of supplier audits 
  • Prepare and submit all necessary documentation in support of regulatory filings (Design Dossier, PMA-supplement, etc.)

Requirements Include:

  • Minimum of 10 years of experience in Medical Devices Industry, preferably in quality/regulatory function, with at least 3-5 years in management role
  • Proven track record of actively working with a product development team through all the quality system requirements including design, development, verification/validation, and design transfer 
  • Knowledgeable of all FDA Requirements within a medical product development environment
  • Experienced in preparing and submitting vigilance reports in EU and Medical Device Reporting (MDR) in US
  • Experienced in developing, implementing, and monitoring all company quality systems to demonstrate compliance with ISO13485, Canadian Medical Device Requirements, CE Medical Device Directives, and FDA requirements 
  • Experience in Interfacing with Clinical group during trials and Bioresearch Monitoring inspection preferred
  • Minimum B.S. in Scientific or Engineering or equivalent, advanced degree (M.S./Ph.D.) preferred
  • Training / certification in FDA 21CFR 820 and/or ISO 13485

Senseonics is an Equal Opportunity Employer and does not discriminate based on race, religion, gender, national origin, color, age, military service eligibility or veteran status, disability, sexual orientation, marital status or any other protected class. We offer competitive salaries and benefits, for consideration, please submit your resume electronically to HR@senseonics.com.

 

Program Manager

01/24/2017

About the Position:

We are looking for a full time Program Manager with 15+ years experience in product development and project management.  Familiarity with Class II or ClassIII medical products would be helpful. An aptitude for detailed project  planning with strong team oriented skills and abilities would be desirable. Person should be self driven and typically works on projects involving more than one functional area. This includes leading the planning, due diligence, and ensuring on schedule implementation of strategic programs within the company product portfolio.

Responsibilities Include:

  • Develops high level project plans and provides  feedback on development strategy, development cost, product cost, project risks, and timelines for each project. 
  • Manage deliverables from multiple cross functional project teams of internal and external personnel through frequent teleconferences and in person meetings to ensure resources are brought to bear in a timely fashion to resolve issues and assess opportunities to demonstrate system level integration readiness.
  • Assess project requirements and manage them to completion; identify personnel resources needs and communicate project status,  present proposals and recommendations to mitigate logistics concerns to management. 
  • Have basic domain background to help proactively identify dependencies in the program which can have schedule impact
  • Work closely with Marketing, Quality & Regulatory, Manufacturing and Clinical functional areas to meet project completion timelines.

Requirements Include:

  • 15+ years experience in program management, medical device experience will be a plus
  • Good understanding of regulated product development
  • Proven skills in understanding customer needs for diagnostic medical devices
  • Good knowledge of documentation and process needs to meet FDA and CE regulatory requirements
  • Experience in managing projects from inception to post-market sustaining
  • BS in a science or engineering field
  • MS/MBA in technical field or business management preferred
  • self-motivated person with a strong execution ability
  • should have communication and inter-personal skills to work effectively in a fast paced team environment with minimal management oversight
  • Must have strong analytical skills to analyze, dependencies in a project, and be able to proactively understand/anticipate the critical paths on projects.

Senseonics is an Equal Opportunity Employer and does not discriminate based on race, religion, gender, national origin, color, age, military service eligibility or veteran status, disability, sexual orientation, marital status or any other protected class. We offer competitive salaries and benefits, for consideration, please submit your resume electronically to HR@senseonics.com.

Systems Engineer

12/23/2016

Position Summary

Systems Engineering function responsible for medical device development projects including working with cross-functional team on tasks such as:  project planning, defining requirements, traceability assurance, testing, problem debugging, and schedule compliance.  Position will work with varied stakeholders modeling performance aspects of the system and defining various interfaces between sub-systems and environments.

Responsibilities:

  • Develops system project plans and provides feedback on development strategy, development cost, product cost, project risks, and timelines for each project
  • Provide expertise on engineering systems for activities such as; planning, analyzing, design & test.
  • Prepare technical reports including Design of Experiments (DOE), external interfaces, internal interfaces, component qualification, product testing, FMEA, statistical analysis
  • Participate in the all phases of development across multiple projects; investigate interchangeability, replacement, cost factors, and ease of manufacture. Coordinate with project team to create and release Product Requirements, Design Specifications and Design Descriptions for assigned designs applicable standards and procedures. Work with all Project team members throughout the development in order to ensure that products are produced in a safe, efficacious and quality manner while keeping within established time frames
  • Communicate project information both within and external to the company

Requirements:

  • Candidate must have strong analytical skills to analyze, dependencies in a project, and be able to proactively understand/anticipate the critical paths on projects
  • BS or MS in engineering (EE,BME) or equivalent.  PhD optional
  • 3+ years experience in design/development of multi-domain (EE,BME) systems; particularly desirable is medical device development experience

Other

  • Full Time, salaried, minimal travel requirements

Senseonics is an Equal Opportunity Employer and does not discriminate based on race, religion, gender, national origin, color, age, military service eligibility or veteran status, disability, sexual orientation, marital status or any other protected class. We offer competitive salaries and benefits, for consideration, please submit your resume electronically to HR@senseonics.com.