Mechanical Engineer

Actalent; United States; On-site; USD 61,992 - 89,544; Full time

Benefits offered by this job

Medical, dental & vision

401(k) Retirement Plan

Life Insurance

Time Off/Leave (PTO, Vacation or Sick Leave)

Job summary

Actalent is seeking a highly skilled Mechanical Engineer IV to lead the design and development of mechanical systems for medical devices. This role involves collaboration across R&D, Quality, and Manufacturing to ensure compliance with clinical needs and regulatory requirements.

The ideal candidate will have over 7 years of experience, proficiency in SolidWorks, and a strong background in regulatory environments. This fully onsite position is based in Saint Paul, MN, and offers a competitive hourly rate.

Qualifications

• 7+ years of experience in mechanical design, 3+ years in medical devices.
• Experience in mechanical verification and validation testing.
• Knowledge of DFM/DFA principles and prototyping methods.

Responsibilities

• Lead mechanical design and development of medical devices.
• Create CAD models and design documentation.
• Develop and execute design verification and validation testing.
• Support design transfer to manufacturing.

Skills

Mechanical design

SolidWorks CAD software

Regulatory knowledge (FDA, IEC, ISO)

Problem-solving

Project leadership

Education

Bachelor's or Master's degree in Mechanical Engineering

Job description

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.

Responsibilities

• 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.

Essential Skills

• 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 SolidWorks 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.

Additional Skills & Qualifications

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

Work Environment

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

Job Type & Location

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

Pay and Benefits

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

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:

• 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)

Workplace Type

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

Application Deadline

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

Equal Opportunity Employer

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.

San Francisco Fair Chance Ordinance

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.

Massachusetts Lie Detector

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.