Mechanical Engineer

Job Title

Mechanical Engineer IV

We are seeking a highly skilled and experienced Mechanical Engineer IV to join our development team. In this role, you will lead the design, development, and optimization of mechanical systems and components for medical devices. You will work cross‑functionally with R&D, Quality, Regulatory, Product Management, and Manufacturing teams to ensure products meet clinical needs, regulatory requirements, and commercial objectives.

• Lead the mechanical design and development of medical devices, from concept through commercialization.
• Create 3D CAD models, detailed drawings, tolerance analyses, and design documentation in accordance with regulatory and FDA QSR requirements.
• Select appropriate materials and manufacturing processes such as injection molding, machining, extrusion, and 3D printing.
• Collaborate with cross‑functional teams to integrate mechanical, electrical, and software subsystems.
• Develop and execute design verification and validation testing, including mechanical performance, biocompatibility, EN60601 safety, and reliability testing.
• Drive risk management activities such as FMEA and fault‑tree analysis and ensure compliance with regulatory and quality standards.
• Support design transfer to manufacturing, including supplier qualification, process development, and sustaining engineering.
• Work with and manage outside vendors.

• Bachelor’s or Master’s degree in Mechanical Engineering or related field.
• 7+ years of experience in mechanical design, with at least 3+ years in medical device development.
• Proficiency with Solid Works CAD software.
• Strong knowledge of DFM/DFA principles, prototyping methods, and manufacturing processes.
• Experience working within regulated environments such as FDA, IEC, ISO.
• Demonstrated track record of taking products from concept through design transfer and commercialization.
• Excellent problem‑solving, communication, and project leadership skills.
• Hands‑on prototyping, testing, and lab experience.

• Experience in risk management activities such as FMEA and fault‑tree analysis.
• Experience in design verification and validation testing including EN60601 safety testing.

The work environment includes both office and manufacturing settings. Engineering teams are located in Minnesota and California.

This is a Contract to Hire position based out of Saint Paul, MN.

The pay range for this position is $45.00 - $65.00/hr.

• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre‑tax and Roth post‑tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long‑term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

This is a fully onsite position in Saint Paul, MN.

This position is anticipated to close on Jun 22, 2026.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccom for other accommodation options.

Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.