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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.

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.

Regulatory Affairs Specialist

03/09/2017

Summary

The 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.

Principal Responsibilities:

  • 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.

Education:

  • Preferred Master's Degree M.S. in a technical discipline

Experience:

  • 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

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.

 

Materials Processing Engineer

12/23/2016

About the Position

We are looking for a full time materials processing engineering  who will lead efforts to develop new processes for treatment and functionalization of sensors in the medical device area for Senseonics. The engineer will work with chemists, electronics engineers, mechanical engineers and medical device experts to scale up inventions and designs from the lab. They will be responsible for the robustness of the processes as well as meeting of product performance specifications.
This role will be part of a larger multi-disciplinary 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 experience in similar situations.

The position requires a candidate with MS or PhD in chemical engineering, applied chemistry, polymer engineering or materials sciences, with 3+ years of industrial experience or a Bachelors degree in these fields with 7+ years of experience.

Responsibilities include:

  • Will develop process for polymer processing and interfacial engineering in the medical devices application space
  • Needs to understand statistics to design robust processes
  • Will understand the chemistry (kinetics and structure), 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:

  • Expertise in Hydrogels, Polymer chemistry, polymer analysis, interfacial sciences polymer processing, process design, statistics, design of experiments
  • 3+ years experience with application of polymers in the medical devices industry
  • Exposure to 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.

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.