Senior Biomedical Systems Engineer

Lumicell • Waltham, MA

11d • Hybrid

About The Position

At Lumicell, we’ll give you the opportunity to harness all that’s within you by working in a mission driven start-up environment with high-performing employees, tackling some of the most important challenges in cancer surgery. We are working to revolutionize the way cancer surgery is performed today, starting with breast cancer. Women in the US have a 1 in 8 lifetime risk of being diagnosed with breast cancer. Every two minutes, a person is diagnosed. Our founder, David Lee lost his wife to breast cancer due to cancer being left behind during surgery. You will be a part of something groundbreaking as we transition from clinical development to our commercial launch.

Lumicell is seeking a Senior Biomedical Systems Engineer to lead the technical definition, integration, and execution of medical device development programs for combination drug/device products. This role is responsible for translating user needs into system-level design requirements, managing design controls, and ensuring that product designs meet performance, safety, and regulatory expectations across development stages.

Requirements

• B.S. or M.S. in Mechanical Engineering, Biomedical Engineering, Bioengineering, Physics, or a related engineering discipline.
• Hands-on experience working within design controls for Class II or Class III medical devices.
• Demonstrated knowledge of medical device design controls (21 CFR 820.30) and risk management principles (ISO 14971).
• Experience documenting design outputs, verification reports, and engineering rationale within a regulated quality system.
• Demonstrated ability to lead system-level medical device development efforts through lifecycle milestones.
• Experience working cross-functionally with systems, software, clinical, regulatory, and quality teams.
• Strong analytical and problem-solving skills with the ability to independently drive technical workstreams.
• Excellent written and verbal communication skills suitable for regulatory documentation and cross-functional collaboration.

Nice To Haves

• Start-up experience preferred.
• Experience developing medical imaging or fluorescent imaging technologies.
• Experience with data analysis tools such as Matlab, Python, ImageJ, etc.
• Experience supporting regulatory submissions (IDE, 510(k), PMA, NDA-adjacent combination products).

Responsibilities

• Define, document, and maintain medical device designs under formal design control in accordance with 21 CFR 820.30.
• Capture user needs and translate them into clear, testable design inputs and system requirements appropriate to development stage.
• Develop system architectures and ensure traceability between user needs, design inputs, design outputs, and verification activities.
• Perform and document risk analyses (e.g., FMEA) by evaluating failure modes and their device-level and clinical effects.
• Contribute to development and execution of bench, laboratory, analytical, and/or animal testing strategies to demonstrate proof-of-concept and verify that design outputs meet design requirements.
• Collaborate with cross functional teams throughout the development lifecycle; including engineering, quality, clinical, regulatory, and marketing teams.
• Manage and communicate product development timelines consistent with program and business objectives.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level