Mechanical Design Engineer

I'm partnering with an innovative medical device company that is transforming the way patients manage injectable therapies y are seeking a Mechanical Design Engineer II to join their growing team and play a critical role in the development of next-generation drug delivery devices.

• Design and develop plastic components and assemblies for medical devices, including injection-molded parts and complex mechanisms
• Apply Design for Manufacturability (DFM) and Design for Assembly (DFA) principles
• Support design verification, validation, and risk management activities
• Participate in IQ/OQ/PQ validation efforts
• Collaborate with Quality, Regulatory, Manufacturing, and Clinical teams
• Contribute to technical documentation, regulatory submissions, and design transfer activities
• Drive product and process improvements while ensuring compliance with industry standards

• Bachelor's degree in Mechanical Engineering or related field
• 5-8+ years of mechanical/product design experience
• 3+ years within the medical device industry
• Strong experience designing injection-molded plastic components and assemblies
• Experience with:
  • ISO 13485
  • ISO 14971
  • cGMP / FDA Design Controls
  • IQ/OQ/PQ Validation

• Lean Manufacturing and/or Six Sigma
• FEA, tolerance analysis, and statistical methods

• 100% company-paid Medical, Dental & Vision coverage for employees and dependents
• 401(k) with company match
• Discretionary Time Off (DTO)
• Potential stock option eligibility based on experience

Please note: This is a fully onsite position in Portsmouth, NH. No relocation assistance is available.