Senior Product Development Engineer

 

Position Title: Senior Product Development Engineer

Position Type: Full Time

Job Type: Experienced

Reporting To/Department: Senior Director, Research and Innovation

 

 

Summary

 

We are 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.

 

 

Essential Duties and 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

 

Education and Required 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

 

Critical Competencies for Success

  • Excellent problem-solving, troubleshooting, and communication skills
  • Detail oriented and highly organized
  • Must be able to work independently and as part of a team, learn quickly, and take on responsibilities outside of this scope of work, as necessary
  • Must have strong patient and user focus and design with patient outcomes in mind
  • Must be resilient and focused with a knack for navigating complex and occasionally ambiguous environments

 

Supervisory Responsibility

  • This position has no supervisory responsibilities

 

Work Environment

  • This job operates in a professional office environment. This role routinely uses standard office equipment such as laptop computers, photocopiers and smartphones.

 

Position Type/Expected Hours of Work

  • 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.

 

Travel

  • Some travel may be expected for this position including internal meetings, conference and or training events

 

EEO Statement

  • Lumicell is an equal opportunity employer

 

Other Duties

  • Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice

To apply for this position, please send your resume to careers@lumicell.com.