Systems/Controls Engineer II

Bausch+Lomb Companies Inc.•Kirkwood, OH

2d•Onsite

About The Position

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.

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.
Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.

Nice To Haves

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).

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.