Senior Product Development Engineer (19-00235) – MA – Newton

 Summary:
Lumicell is seeking a highly-motivated Product Development Engineer to work in a dynamic, fast-paced start-up environment. This is an exciting opportunity to join a company that has received excellent press and generated promising clinical data while still in its nascency. A proven track-record in medical device development with a focus on imaging or optics is vital. The successful candidate is a proactive and independent problem solver who integrates well into existing company processes while adapting to new roles as necessary. The chosen candidate will be responsible for managing the development of Lumicell's commercial products, translating user requirements into product specifications and designs and helping to plan and execute experiments to determine whether specifications have been met.
Responsibilities:

  • Design and development of cutting-edge imaging technologies
  • Fast prototyping, verification testing, feasibility studies and implementation of imaging products
  • Interacting with end users and the clinical team for requirement and specification development
  • Data analysis in support of verification and validation studies
  • Interfacing with and managing both in-house and contract engineers in product development
  • Documentation in compliance with Lumicell's Quality System and Design Control Procedure
  • Conceive of effective manufacturing process flows and direct the implementation of new processes;
  • Characterize new product performance to provide design feedback. Employ world-class testing capabilities using both empirical methods and simulation to prove high quality product performance.
  • Collaborate closely with the manufacturing team to transfer products into production;
  • Communicate status updates to the Executive Leadership Tea within the context of a structured phase-gate process.

Qualifications/Work Experience:

  • Advanced Degree in Physics, Mechanical Engineering, Optical Engineering or related field
  • The ideal candidate will have >3 years of experience in the medical device field with a product development focus
  • Experience with design for manufacture
  • Experience with medical imaging, fluorescence imaging and/or optoelectronics is highly desired.
  • Familiarity with 21 CFR 820, ISO 13485, IEC 60601 and IEC 62304 is also highly desired.

Source: Job Diva – Job Listing

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