Product Development Engineer, Med Device
1 month ago
Be a part of something altogether life-changing Working at Biomeme in the Biotechnology industry means being at the forefront of providing healthcare diagnostic technology that empowers anyone, anywhere.
Who we are looking for…
Biomeme is seeking a Product Development Engineer who enjoys working in a fast-paced, team-oriented environment, has a transformational mindset, and values the opportunity to support our product development team, helping to design, develop, and commercialize the next generation of our groundbreaking diagnostic products.
What you will do…
• Contribute to the design and development of medical diagnostic devices and consumables through all stages from concept to customer.
• Optimize existing designs, materials, and manufacturing processes to facilitate product improvement.
• Participate in development of documentation to ensure compliance under 21 CFR Part 820.
• Develop, perform, and document test procedures for verification and validation.
• Participate in design reviews and contribute to the risk management process.
• Complete design drawings and models in Solidworks (or equivalent) and create prototypes to progress the development through its design stages.
• Coordinate and assist in corrective and preventative action activities and solutions.
• Communicate with strategic vendors and suppliers.
What you bring to the table…
• 4 year degree in applicable field of study (Mechanical or Biomedical Engineering, eg.)
• 3-5 years of product development experience in a regulated industry (Medical Device)
• Experienced designer of injection molded components
• Self-directed hands-on prototyping and problem-solving skills
• Ability to work with small instrumentation
• Proficiency using Solidworks and a PDM application such as Solidworks PDM or Teamcenter
• Good written and verbal communication skills.
It would be great if you have experience with…
• Microfluidic systems.
• Fault-tolerant electromechanical systems.
• Design for Manufacture – injection molding, machining, stampings.
• Thermal modeling and engineering.
• Optical engineering.
• Materials selection (molding resins, metals, adhesives, films).
• Label design and control
Due to ITAR compliance, this position requires candidates to be a U.S. Citizen, Permanent Resident Alien, or Protected Individual per 8 U.S.C. 1324b(a)(3)
Biomeme is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law.
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