Title: Device Development Engineer

Location: New Haven, CT

Duration: 12 Months

PARKING WILL BE REIMBURSED

Job Description:

• Manage medical device test method and specification development, including test method development, validation, transfer, and life cycle management.
• Support the laboratory operation such as sample inventory, equipment qualification and maintenance.
• Conduct characterization for device function, assembly, manufacturability, etc. using both CAE and traditional engineering techniques.
• Test mechanical or electromechanical systems on bench top models or production representative units, during design development and verification.
• Consult with third parties such as specialist manufacturers and toolmakers.
• Communicate effectively, both verbally and in writing, internally across departments and with external suppliers.
• Comply with the Company’s quality assurance requirements as well as applicable regulatory requirements.

You will need to have:

• Experience in design control activities.
• Knowledge of primary containers and drug delivery.
• Understanding of mold, fixture design and build as well as application of validation processes (IQ/OQ/PQ).
• Interface with the medical device vendor and tooling company.
• Knowledge of the regulatory and compliance requirements of device design controls and combination products (i.e. FDA QSR 21 CFR Part 4 and 820/ISO13485 quality system requirements).
• Work comfortably in a controlled environment with and around biological, infectious, and hazardous materials.
• Bachelor’s degree in Engineering (Biomedical, Chemical, Mechanical, or Electrical Engineering) plus
• 1 to 3 year experience in laboratory. Experience with injector based combination product preferred.

If you are not interested in looking at new opportunities at this time I fully understand. I would in that case be appreciative of any referrals you could provide from your network of friends and colleagues in the industry. We do offer a referral bonus that I’d be happy to extend to you if they turn out to be a great fit for my client.

Thank you for your time and for your consideration. I look forward to hearing from you.