Senior Product Development Engineer

Lumicell • Waltham, MA

1d • 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 Product Development Engineer to work in a dynamic, fast-paced start-up environment. The Senior Product Development Engineer will drive design and development execution for Lumicell’s fluorescence imaging technologies in new/expanded indications. A successful candidate will have a proven track-record in medical device product development.

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.
• Experience in mechanical design and prototyping, including CAD modeling (e.g., SolidWorks or equivalent), tolerance analysis, and design for manufacturability.
• Experience developing and executing bench, laboratory, and/or preclinical testing to demonstrate proof-of-concept and verify performance requirements.
• Working knowledge of medical device design controls (21 CFR 820.30) and risk management principles (ISO 14971).
• 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, with working knowledge of optical characterization methods.
• Demonstrated ability to gather and synthesize user feedback (e.g., surgeons, clinical collaborators) and translate it into practical design iterations.
• Experience working in surgical/intraoperative environments.
• Experience supporting clinical or translational imaging products.

Responsibilities

• Lead the design, prototyping, development, and iterative refinement of medical device subsystems and assemblies.
• Translate system requirements and user needs into practical design solutions and manufacturable prototypes.
• Drive hands-on development efforts including mechanical, optical, and hardware sub-systems integration.
• Lead development and execution of bench, laboratory, analytical, and/or animal testing strategies to demonstrate proof-of-concept and verify that design outputs meet performance requirements.
• Support regulatory documentation through preparation of verification reports and performance summaries.
• Manage development timelines and coordinate cross-functional activities to meet programming milestones.
• Gather structured feedback from users and internal stakeholders; synthesize findings into actionable design improvements.

What This Job Offers

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