Design Engineer II

The Design Engineer II supports the development, improvement, verification, and transfer of medical device products within a regulated engineering organization. This role focuses on creating robust product designs, maintaining complete and accurate design documentation, supporting design verification activities, and partnering closely with manufacturing, quality, regulatory, supply chain, and commercial teams. The position is ideal for a hands-on, detail-oriented engineer who thrives in a structured medical device environment and is motivated by developing products that improve patient care., * Design, develop, and improve medical device products and components from initial concept through production release.

• Create and maintain 3D CAD models, detailed drawings, assemblies, bills of material, specifications, and related engineering documentation.
• Support product development activities including feasibility builds, prototype testing, design reviews, design verification, validation support, and design transfer to manufacturing.
• Develop test methods, write test protocols, execute or coordinate testing, analyze results, and document conclusions in accordance with internal quality system requirements.
• Collaborate with Manufacturing Engineering and Operations to enhance manufacturability, assembly processes, yield, product quality, and scalability.
• Support design changes, engineering change orders, product line extensions, supplier changes, and continuous improvement initiatives.
• Participate in risk management activities including risk analysis, FMEA, mitigation planning, and post-market product support.
• Investigate product performance issues, nonconformances, complaints, and manufacturing challenges using structured problem-solving and root cause analysis tools.
• Work with suppliers and contract manufacturers on component design, manufacturability, specifications, tooling, inspection requirements, and qualification activities.
• Maintain an accurate and complete Design History File and technical documentation to support FDA and other applicable regulatory requirements.
• Apply design for manufacturing and assembly principles to ensure efficient production and high product reliability.
• Contribute to process validation and inspection method development to ensure consistent product quality.
• Communicate technical information clearly to cross-functional stakeholders and participate actively in design and project reviews.

• Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, or a related technical discipline.
• 2+ years of engineering design or product development experience, preferably within medical device or another regulated industry.
• Proficiency with 3D CAD software such as SolidWorks or equivalent.
• Experience creating engineering drawings, tolerance schemes, assembly documentation, and technical specifications.
• Working knowledge of design controls, verification testing, documentation practices, and structured engineering change processes.
• Strong mechanical aptitude with the ability to support hands-on prototyping, troubleshooting, testing, and manufacturing support.
• Ability to work effectively in a cross-functional environment and collaborate with manufacturing, quality, regulatory, supply chain, and commercial teams.
• Clear and concise communication skills for presenting technical information to diverse stakeholders.
• Experience with mechanical design, CAD, and 3D modeling in support of new product development.
• Understanding of medical device development practices and quality systems in a regulated environment.

Additional Skills & Qualifications

• Medical device product development experience, particularly with Class I or Class II devices.
• Experience with endoscopy, visualization systems, minimally invasive devices, catheters, small electromechanical assemblies, or disposable and reusable devices.
• Knowledge of FDA Quality System Regulation and relevant ISO standards, including usability, sterilization, biocompatibility, and regulatory submission support.
• Experience designing plastic, machined, molded, stamped, or miniature precision components.
• Familiarity with design for manufacturing and assembly, supplier qualification, process validation, and inspection methods.
• Experience with root cause analysis tools, statistical analysis, and design verification planning.
• Background in PCB layout or small electromechanical assemblies in medical or high-reliability applications.
• Ability to navigate dynamic priorities and contribute innovative solutions within a fast-paced product development setting.

This is an on-site role based in Plymouth, MN, within a regulated medical device development framework. The work environment emphasizes close collaboration among engineering, manufacturing, quality, regulatory, and operations teams, with engineers expected to manage dynamic priorities and contribute to innovative solutions. The facility includes cleanroom and controlled environment areas, and team members comply with all safety, personal protective equipment (PPE), and environmental requirements. Work is hands-on, leveraging advanced technologies in medical device engineering, and involves both office-based design activities and time spent in lab, cleanroom, and production settings.

Job Type & Location

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

Pay and Benefits

The pay range for this position is $45.00 - $55.00/hr.

Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

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

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing winner for both client and talent service.