Systems/Controls Engineer II

Bausch & Lomb GmbH; Northern (KY); Hybrid; USD 95,000 - 130,000; Full time

Job summary

Bausch + Lomb is seeking an experienced engineer to support a medical device software program. The role involves in-sourcing third-party designs and software documentation, coordinating with suppliers, and ensuring cybersecurity and regulatory compliance.

The candidate will manage multiple assignments independently, plan and execute software verification/validation, and contribute to the continued advancement of eye health technology.

Qualifications

• Bachelor's 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.

Responsibilities

• Bring third-party electronic designs in-house and generate technical requirements documents.
• Bring third-party software documentation in-house and refactor SRS, SDS, SAD, and related documents.
• Document accessory laser fiber manufacturing end of line test fixturing and processes.
• Document and validate field service calibration, software upgrade process, and tooling.
• Execute lab-based testing to verify and validate documentation.
• Plan and execute software full regression and hardware testing with test protocols and reports.

Skills

MCU design

Firmware coding

Requirements thinking

Communication

Self-motivation

Education

Bachelors in Engineering

Tools

Altium

IAR Suite

Aras PLM

Documentum D2

MS Office

Job description

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Bausch + Lomb (NYSE/TSX: BLCO) is a leading global eye health company dedicated to protecting and enhancing the gift of sight for millions of people around the world—from the moment of birth through every phase of life. Our mission is simple, yet powerful: helping you see better, to live better.

Our comprehensive portfolio of over 400 products is fully integrated and built to serve our customers across the full spectrum of their eye health needs throughout their lives. Our iconic brand is built on the deep trust and loyalty of our customers established over our 170-year history. We have a significant global research, development, manufacturing and commercial footprint of approximately 13,000 employees and a presence in approximately 100 countries, extending our reach to billions of potential customers across the globe. We have long been associated with many of the most significant advances in eye health, and we believe we are well positioned to continue leading the advancement of eye health in the future.

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

• 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).

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

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.

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.