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.
Position Summary:
The candidate will fill a critical role providing technical leadership on manufacturing projects as part of the product development/engineering team. In this role, the Principal Manufacturing Engineer is responsible for the planning and execution of manufacturing and process activities to provide innovative, functional, and cost-effective solutions to support product development and commercialization of medical devices. The candidate is expected to work with external contract manufacturers partners, suppliers and external resources. The candidate will ensure that robust processes are in place through adherence to established quality, design control processes and good engineering / manufacturing practices.
- This role requires light travel (as needed) to Contract Manufacturer Locations (NH based)
- Candidate may work remotely 1 – 2 day(s) of the week as needed.
Responsibilities:
- Able to manage multiple contract manufacturers who produce various aspects of medical devices.
- Able to collaborate with external suppliers and Contract Manufacturers to create, define, and document manufacturing processes, as well as their failure modes and related risks (i.e., pFMEA)
- Able to create and execute validation and qualification activities (i.e., IQ/OQ/PQ) for complex, optical devices.
- Must have a strong familiarity with medical device manufacturing regulations (i.e., 21 CFR 820 – etc.).
- Should have a working knowledge of design control for medical devices (i.e., 21 CFR 820.30 – etc.)
- Experience in creating manufacturing / process related protocols and methods, managing progress, interpreting data, and making informed recommendations.
- Work with R&D, Marketing, Quality and Manufacturing team members to identify manufacturing, material and/or product improvement opportunities and provide innovative system and component solutions.
- Perform detailed design and process analysis and provide feedback or approval for detailed component and equipment specifications.
- Ability to create/modify site procedures and train associates as required to commercialize manufacturing changes.
- Familiar with Change Management for product, labeling and packaging.
- Apply knowledge of general engineering principles, materials, risk management, and reliability to achieve product requirements.
- Design, fabricate and procure tools and fixtures to support manufacturing needs
Additional required skills:
- Basic SolidWorks (or OnShape) CAD skills, PDM experience
- Excellent verbal and written communication skills, strong decision making and problem-solving skills.
- Able to adapt to shifting priorities and work in a fast-paced environment.
- Able to take initiative and produce independently.
- Practical, hands-on approach to problem solving.
- Ability to prioritize tasks and resources accordingly based on company needs.
Experience / Requirements
- BS or MS engineering degree, preferably Mechanical or Manufacturing
- 15+ years of relevant experience in medical device or pharmaceutical industry working in a team-based environment.
- Knowledge and understanding of applicable medical device manufacturing regulations (e.g., 21 CFR 820, cGMP, ISO-13485 – etc.)
- Experience supporting/producing low volume optical-mechanical devices
- Experience supporting/producing low volume sterile disposables
- Experience with Class III Medical Devices
- Prior experience with endoscope, imaging, or machine vision
- Experience with plastics, injection molding and assembly of small parts
- Process/Operations excellence training or certification (ex. Six Sigma, Lean, Green or Black Belt)