Objective: Candidate will support a medical device program through post-submission activities, including in-sourcing third-party electrical designs and software documentation, supplier software support, cybersecurity documentation, and software/electronic verification. As an E2, the candidate is expected to manage multiple assignments independently.
Responsibilities:
• Bring third-party electronic designs in-house (porting schematics & layouts to our toolset) and generate technical requirements documents.
• Bring third-party software documentation in-house and refactor SRS, SDS, SAD, and related documents for future B+L development and maintenance.
• Document accessory laser fiber manufacturing end of line test fixturing and processes for externally manufactured accessories for future reference.
• Document and validate field service calibration, software upgrade process, and tooling for future reference.
• Execute lab-based testing to verify and validate documentation.
• Complete cybersecurity documentation set with the team to satisfy FDA premarket guidance.
• Plan and execute software full regression and hardware testing on the latest version, including authoring/maintaining test protocols and reports for both functional and cybersecurity requirements.
• Perform software verification & validation per the B+L QMS, including traceability to product/system requirements.
• Plan and execute validation of the service software, coordinating with the service group and other relevant stakeholders.
• Provide software support for contract manufacturers, including maintaining the associated software documentation (requirements, design, and tests).
• Apply relevant industry standards and government regulations.
Requirements:
Minimum requirements
- Bachelors degree in Engineering (Electrical, Computer, or Software) or Computer Science with 3-7 years experience in microcontroller board design and firmware programming.
- Demonstrated ability to read, write, and reason about software requirements, design, and test artifacts.
- Excellent communications & organizational skills.
- High degree of self-motivation and direction
Preferred requirements
- Experience at a medical device company performing software verification & validation, full regression testing, and authoring/maintaining software documentation (SRS, SDS, SAD, test protocols and reports).
- Working knowledge of IEC 62304 (medical device software life cycle), ISO 14971 (risk management), IEC 62366, FDA premarket software guidance and software Level of Concern (e.g., 62304-aligned), 21 CFR Part 11, and EU MDR.
- Working knowledge of medical device cybersecurity practices and the current FDA premarket guidance.
- Experience remediating or in-sourcing third-party software documentation.
- Comfort with scripting / test automation and with reading source code (e.g., C/C++, C#, Python) is a plus.
- Experience using our tool chain (Altium, IAR Secure Development Suite, MS Office, Aras PLM, Documentum D2).
U.S. based employees may be eligible for short-term and/or long-term incentives. They may also be eligible to participate in medical, dental, vision insurance, disability and life insurance, a 401(k) plan and company match, a tuition reimbursement program (select degrees), company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive sick time, floating holidays and paid vacation.
