Senior Biomedical Systems Engineer

Overview

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.

• 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.

• 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 work streams.
• Excellent written and verbal communication skills suitable for regulatory documentation and cross-functional collaboration.

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

• This is a full-time position, 40 hours per week. Days and hours of work are Monday through Friday during business hours. Occasional evening and weekend work may be required as job duties demand.
• This is a Hybrid position, and the ability to be on-site 3 days a week is required.

Lumicell is committed to a Diverse and Inclusive workplace. We strive to recruit candidates who will bring inclusive mindsets and contribute to our values. Lumicell is an Equal Opportunity Employer and does not discriminate based on race, national origin, gender, gender identity, sexual orientation, protected veteran status, disability, age, or other legally protected status. Lumicell will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

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