Mechanical Design Engineer

Mount Kemble Search Group; Portsmouth (NH); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Medical, dental & vision coverage

401(k) with company match

Discretionary Time Off (DTO)

Stock option eligibility

Job summary

Mount Kemble Search Group is partnering with a medical device company in Portsmouth, NH, seeking a Mechanical Design Engineer II to design injection-molded plastic components and assemblies for next-generation drug delivery devices.

You will apply DFM/DFA, support verification/validation, and collaborate with Quality, Regulatory, Manufacturing, and Clinical teams to ensure regulatory compliance and robust product transfer.

Qualifications

• 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.

Responsibilities

• 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.

Education

Bachelor's degree in Mechanical Engineering or related field

Job description

I'm partnering with an innovative medical device company that is transforming the way patients manage injectable therapies at home. They 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.

What You'll Do

• 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

What We're Looking For

• 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

Preferred Experience

• 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.