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Vacancies

Sr. Principal Systems Engineer

07/22/2024

Department:

 

Sr. Principal Systems Engineer

Reports To:

 

Director, Systems & Hardware Engineering

FLSA Status:

 

Exempt

Job Location:

 

Germantown, MD

Job Summary:

The Senior Principal Systems Engineer will develop next generation optical glucose sensor platforms, build system architecture for sensor interfaces and connectivity to microcontroller based wearable systems, mobile phones, and cloud-based systems for next generation wireless sensor platforms.

Duties and Responsibilities include, but are not limited to:

  • Analyze, evaluate, define and plan innovative solutions to complex technical problems relevant to our patients and clinicians
  • Develop and apply expert knowledge in multiple technical specialties related to systems, chemical, mechanical, electrical, firmware, and software engineering for medical devices
  • Create complex and reliable system architectures involving implantable medical devices with multiple wireless interfaces to wearable medical devices, mobile phones, and cloud-based systems.
  • Analyze retrospective field data and prospective failure modes and create new requirements and design to mitigate these failure modes to create safe and effective medical devices.
  • Serve as technical contributor in the development, application, implementation and evaluation of mathematical models and signal processing algorithms for processing of the data returned from Eversense glucose sensors
  • Provide systems engineering expertise to improve the accuracy, stability and overall performance of the Eversense glucose sensors
  • Work with internal staff as well as external consultants and vendors to develop and test the Eversense glucose sensor system and external control systems on mobile phones and the cloud.
  • Employ scientific and engineering principles to foresee technical and schedule risks and to develop and implement appropriate mitigation approaches to minimize risk and maximize value to our patients and clinicians
  • Maintain technical skills and knowledge at a high professional level

Knowledge, Skills, Abilities and Requirements:

  • Master’s degree or Ph.D. in Engineering (Electrical, Mechanical, Biomedical, Chemical, Software or Optical), Computer Science, Physics, or math, or related or equivalent subject
  • Experience in performing modeling & simulation, preferably using MATLAB
  • Excellent oral and written communication skills
  • Extensive experience in Systems Engineering.
  • Extensive familiarity Near Field Communication (NFC) and Bluetooth wireless communications
  • Technical expertise and experience in several of the following areas: optical sensing, optical instrumentation, biophysics, mathematical modeling, signal processing and stochastic processes
  • Minimum of 5 years of mathematical modeling, R&D, or product development experience
  • Product development experience in the medical device field

Principal Mechanical Engineer

06/26/2024

Main Responsibilities:

  • Architect, Design, implement and evaluate mechanical engineering designs which meet defined product requirements and design goals while being highly manufacturable, reliable and optimum cost for the business.
  • Responsible for decision making and documentation based on engineering analysis/testing through excellent analytical and communication (verbal and written) skills
  • Responsible to Develop, Design and implement test methodologies that support characterization and verification of product requirements and design specifications.
  • Collaborate with Vendor, Process Development and Quality for manufacturability (DFM), manufacturing test development and resolution of production issues or field complaints.
  • Conduct all activities and deliverables following all applicable internal procedures based on applicable medical device regulatory requirements for design and manufacturing, including medical device materials, processes, and GMP (Good Manufacturing Practices).
  • Develops high level project plans and provides feedback on development strategy, development cost, product cost, project risks, and timelines for each project.
  • Assess project level needs (including resourcing) and manage them to completion; communicate project status, present proposals and recommendations to mitigate project concerns to functional/program management.
  • Mentor colleagues and/or direct work of other more junior level engineers.
  • This role will be an onsite role with the expectation of being at the location at least 3 days a week on average.

Educational Requirements:

  • Bachelor of Science in Mechanical Engineering.
  • Master of Science in Mechanical Engineering/PhD in technical field would be a plus

Knowledge, Skills, Abilities and Requirements:

  • 15+ years of experience in mechanical engineering design, with at least 3+ years of regulated industry experience
  • Proven skills in understanding customer needs for diagnostic medical devices or wearable medical devices, or implanted medical devices in a regulated environment
  • Good knowledge of tools such as SolidWorks, and familiarity with other mechanical engineering tools.
  • Familiarity with design process and documentation needs to meet regulatory requirements would be a plus
  • Experience in managing projects from inception to post-market sustaining
  • Familiarity with Class II or Class III medical products would be helpful.
  • Have a significant background in mechanical engineering for electronic devices to help proactively identify dependencies between mechanical and electrical requirements of the program

APPLY HERE

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.

Principal Software Systems Analyst

07/19/2024

Department:

 

Product Development

Reports To:

 

Director, Software Engineering

FLSA Status:

 

Exempt

Job Location:

 

Remote

Job Summary:

Senseonics is looking for a talented and experienced Principal Software Systems Analyst to join our dynamic team.

The ideal candidate should possess a minimum of 15 years of experience, demonstrating a deep understanding of integrated software systems and effective collaboration with multiple diverse software teams, including Mobile, Web, Cloud, and 3rd party partner interface systems and the effective application of Agile processes with built-in quality and compliance.

In this pivotal role, you will be responsible for leading the definition and implementation, including on-going process documentation, training, and on-boarding processes to new team members, to our critical Agile processes with compliance into our Software Development Lifecyle (SDLC) and Product Lifecycle (PLC) processes.

This will include both critical processes, tool selection, use, and administration for execution of requirements authoring, review, and approvals, in coordination with Product Management and Quality Assurance teams. This also includes product development planning, in coordination with software team Scrum Masters, joint software systems design and test teams for quality-based designs, integrated testing, QA handovers, release baselining and documentation for product delivery, and on-going change management.

The successful candidate will be self-driven, with a proven track-record of working effectively with cross-functional teams, including Product Marketing, Product Management, Quality Assurance, Customer/Patient Support, and Regulatory stakeholders, ensuring highest quality and compliance throughout the product lifecycle.

Duties and Responsibilities include, but are not limited to:

  • This role will be an integral part of the Software Engineering leadership, to initiate and drive Agile execution integrated with iterative compliant process across all Mobile, Web, Cloud, Support, and Partner Interface Systems sub-product software development efforts.
  • Working closely with Software and Systems R&D leadership, you will champion best practice adoption, assisting the team in adopting Agile development and product lifecycle best practices, and fostering a culture of continuous improvement. This will include authoring and collaborating on the SDLC Standard Operating Policies and Procedures (SoPs) and associated Work Instructions (Wis) to assure Agile process execution are consistent across all software development efforts (for both in-house and contracted efforts).
  • Responsible for authoring (and/or coordinating other authors) for Iterative, Feature-based, decomposed software requirements development, review, approval, and change management. This will include, the evaluation, proof-of-concept execution, and eventual roll-out of a modern, iterative and compliant requirements management toolset.
  • Actively participate, embedded as a member within the software engineering team, in Program Increment (SaFE) planning and associated Sprint planning and execution sessions, including risk  assessment, resource estimates and constraints, quality assurance handover criteria, and other activities ensuring backlogs are appropriately prioritized through grooming, sprint planning, and post sprint review, handovers, and retrospective sessions.
  • Serve as the key leader and liaison between Product Management and Software Engineering (including Scrum Masters) for effective requirements development, approval, planning (eng. estimations), and change management with Product Management, assuring compliant-driven DoR (Definition Of Ready). 
  • Also serve as the key leader and liaison between Software Engineering (including Scrum Masters), and Quality Assurance to assure all quality processes, baselining, and Agile process execution are consistent across all software development efforts (both in-house and contracted efforts), and deliverables to Quality Assurance (handovers) meet a compliant-based DoD (Definition Of Done) for all product features.
  • Work closely with release teams and processes, including DevOps (CI/CT), to define and create required release Design History File (DHF) documents and other quality or risk related areas impacting overall delivery cycle time, efficiencies, security and compliance in medical device product development.
  • Initiate and drive effective Change Management as an intake for software updates (field issue, bug, new feature, configuration), including risk assessment, root cause, complexity analysis, and classification of change, to drive to effective approval and alignment to change prioritization.

Knowledge, Skills, Abilities and Requirements:

  • BS in an Engineering field or strong relevant experience in Software Product Development with strict adherence to quality-based SDLC processes. Versed in Agile w/ Compliant process experience required.
  • Medical Device or Pharmaceutical product standards and experience is a plus, but not required.
  • 5+ years of experience in leading and participation in the definition and management of Software Development Lifecycle processes (SoPs, Wis), ideally with multiple, cross-functional software development teams.
  • 8+ years of experience is applying these processes to Mobile Applications (iOS and Android), Web Applications (both Cloud and On-Premise), and User and Engineering Support Systems for Release Execution (incl DevOps), and Change Control.
  • 10+ Experience in managing and coordination of activities as part of Agile Backlog Grooming, with primary focus on formal Requirements Management processes and tools, for inputs into Agile/Scrum sprint cycle execution, and resultant deployment activities and criteria for quality assurance handovers and baselined release documentation.
  • Self-motivated with interpersonal skills to work effectively with multiple teams, in a fast-paced environment.
  • Effective oral and written communication skills, with the ability to establish and maintain respected and cooperative working relationships.
  • Deep experience in the use of Project Management, Sprint Planning and Execution, and Collaboration Tools such as Smartsheet/MS Project, JIRA/Azure DevOps, Confluence/SharePoint/Teams, etc.
  • Expert knowledge of Agile/Scrum development methodology, with understanding of engineering-level estimations, complexity, and prioritization, as well as Agile execution meetings (i.e. Golden Calendars) and team performance artifacts, velocity, and metrics.
  • Knowledge of modern DevOps, CI/CD/CT processes and tools, App store deployments, as well as Modern Cloud/SaaS architectures, security, and deployment preferred.
  • Strong understanding of standard software engineering design, development, and test key principles, theories, and concepts.

Principal Electrical Engineer

07/05/2024

Department:

 

Product Development

Reports To:

 

Director, Systems & Hardware Engineering

FLSA Status:

 

Exempt

Job Location:

 

Germantown, MD

Job Summary:

We are looking for a Principal Electrical Engineer with 12+ years’ experience in design and development of Application Specific Integrated Circuits (ASIC) and micro-controller based embedded systems, specifically for battery powered medical devices. In this role, you should be able to claim significant responsibility for successful design, debug, and launch of embedded electrical systems/products. Familiarity with Class II or Class III medical products would be very desirable, with knowledge of regulated design and development process. Candidate should have an aptitude for identifying root cause of performance/quality issues based on field data, returned product and test analysis.

Duties and Responsibilities include, but are not limited to:

  • Participate in 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 following applicable standards and procedures.
  • Work with all project team members throughout the development to ensure that products are produced in a safe, efficacious and quality manner while keeping within established time frames.
  • Identifies and resolves issues and communicates status to peers and manager.
  • Ensures completeness, accuracy, and testability of product requirements.
  • Develops test approach and methods, writes and performs test protocols and writes reports.
  • Prepares technical reports, Failure Modes Effects Analysis (FMEA), and statistical analysis
  • Establishes engineering test capabilities and maintains engineering test equipment.
  • Responsible for development and release of engineering design documentation
  • Contributes to intellectual property portfolio, submitting records of invention and patent disclosures.
  • Building system architecture for sensor interface and connectivity to wearable and mobile devices using technologies such as near field communication (NFC) and Bluetooth.
  • Design, development, and deployments of sensor test systems for both characterizing all levels of sensor functionality and for in-line manufacturing test/calibration of sensors.
  • Ability to provide technical leadership to other engineers.

Knowledge, Skills, Abilities and Requirements:

  • BS with 12+ years, MS with 10+ years or Ph.D. with 8+ years in Electrical Engineering, or equivalent
  • Extensive experience in mixed signal schematic capture, PCB design and fabrication
  • Extensive experience in design and test of battery powered ASICs and microcontroller systems.
  • Proficient using industry grade schematic, simulation, layout and CAD software tools.
  • Proficient in antenna design for implantable and external medical devices.
  • Working knowledge of RFID/NFC, Bluetooth, and battery embedded technologies.
  • Data analysis with software tools such as Excell, MATLAB, or Minitab.
  • Ability to write test scripts or software in languages such as C/C++, MATLAB, or Python
  • Ability to design, build, and test manufacturing test fixtures.

APPLY HERE

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.