Manufacturing and Production
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Job: Senior Product Design Engineer Senior Product Design Engineer, NIRSense, a Bionica Labs company, Raleigh, NC
Senior Product Design Engineer Senior Product Design Engineer
Raleigh, NC 27606 United States
Compensation package will be commensurate with the successful applicant’s experience. Anticipated hiring range is $95,000-105,000.
Manufacturing and Production
We are seeking an experienced product design engineer to fulfill a broad set of engineering objectives. This person will help expand our prototype design and manufacturing capabilities from individual prototype iterations to wearable systems manufactured at commercial scale.
Lead the mechanical design of compact, wearable systems that involve digital and analog circuits, microcontrollers, optics, communication components, and other electrical components
Vet domestic and international manufacturing sources for NIRSense systems with a focus on manufacturing for scale and commercialization
Work with electrical engineers to integrate PCB components with flexible or rigid enclosure designs that conform to the human body
Check manufactured parts for accuracy to design intent and engineering tolerances
Translate user needs and functional requirement documents into specific design implementations
Follow best practices for design controls and quality management systems including version control, configuration management, secure and compliant data storage and handling
Coordinate prototyping recipes and practices between NIRSense engineering team and external manufacturing, material supply, and engineering vendors
Provide support to customers on-site and remotely for stage-gated device test milestones
Report to the Director of Engineering
B.S. or M.S. in Mechanical or Biomedical Engineering or a related field plus industry experience in design for wearable devices
Heavy experience with Solidworks for designing rigid or flexible enclosures, molds, and optical interface
Experience in scaling up prototypes toward production, specifically with biosystems
Familiarity with Design for Manufacturing (DFM) and Design for Test (DFT) practices
Experience designing products to meet the requirements of IEC 60601-1 and 60601-1-2 medical device safety standards
Familiarity with material selection and testing per the ISO 10993 biocompatibility safety standard, specifically body-contacting elastomers.
Experience generating risk analysis documentation per ISO 14971
(Preferred) Design experience with optical systems interfacing the human body
(Preferred) Experience working with medical-grade, skin-contacting adhesives
(Preferred) Experience designing products for military applications requiring MIL-STD-810 compliance
(Preferred) Prior experience with medical devices, working with startups, and with a local network is preferred but not required
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