Design Assurance Engineer

Job Description

Job Description

Job Title: Design Assurance Quality Engineer

Job Description

The Design Assurance Quality Engineer provides quality engineering support for new product development projects from initial concept through design transfer and commercialization, while also supporting sustaining engineering activities for existing medical device products throughout their lifecycle. This role collaborates closely with design engineering, manufacturing engineering, operations, supplier quality, business development, and quality teams to ensure customer, quality, and regulatory requirements are effectively integrated into product development and ongoing product support. The engineer leads and supports design controls, risk management, verification and validation, supplier and material qualification, design transfer, and product and process change activities in accordance with the Quality Management System and applicable regulatory requirements.

Responsibilities

• Execute design, development, and validation activities throughout the product lifecycle in accordance with project scope and quality and regulatory requirements.
• Support and apply formal design control processes to develop cost-effective, robust, and efficiently manufacturable medical device products.
• Contribute to project deliverables that comply with medical device regulatory requirements and relevant EN standards.
• Translate customer specifications and requirements into clear, concise performance and functional requirements for product design and process development.
• Plan, conduct, and document engineering evaluations, characterizations, design of experiments (DOE), bench testing, and other verification activities to improve and confirm design and process capabilities.
• Lead and support risk management activities, including development and maintenance of DFMEAs, PFMEAs, and related risk analyses.
• Train and guide development technicians and operators in hands-on prototyping, testing, and process development activities.
• Execute document change requests and ensure effective training of development and production operators and technicians on updated documentation and procedures.
• Design, procure, install, qualify, document, and provide training on new tooling and fixturing to support manufacturing and development needs.
• Evaluate and implement new technologies and ideas to improve products, processes, and overall manufacturing capability.
• Use statistical tools and data analysis to make sound development decisions and enhance process capability and product performance.
• Develop, refine, and maintain manufacturing procedures, test methods, and inspection plans to ensure quality requirements are met and manufacturing risks are mitigated.
• Collaborate with cross-functional teams including design engineering, manufacturing engineering, operations, supplier quality, business development, and quality to ensure alignment on product requirements and project objectives.
• Support design transfer activities to ensure production readiness and successful transition of new products into manufacturing.
• Provide ongoing quality engineering support for sustaining engineering activities and product and process changes throughout the product lifecycle.
• Effectively document technical and quality activities, including protocols, reports, risk files, and quality records, in accordance with the Quality Management System.

Essential Skills

• Bachelors degree or technical degree in engineering or a related technical field, or equivalent combination of education and experience.
• Minimum of 5 years of experience in a medical device manufacturing, product development, quality engineering, or related regulated environment.
• Experience with medical device design controls and new product development processes.
• Experience with product and process verification and validation activities, including protocol development, execution, and documentation.
• Experience with DFMEAs, PFMEAs, and risk management activities in a regulated environment.
• Working knowledge of applicable FDA quality system requirements and ISO-based quality management standards.
• Understanding of design transfer, manufacturing processes, production readiness, and sustaining engineering activities.
• Strong project management and organizational skills with demonstrated initiative and ownership of assigned projects.
• Strong verbal and written communication skills, including the ability to clearly document technical and quality activities.
• Ability to use statistical tools to analyze data and make informed development and process improvement decisions.

Additional Skills & Qualifications

• Experience in medical device quality engineering within a highly regulated environment.
• Experience in plastics engineering, design assurance, and validation for medical device components and assemblies.
• Experience with SolidWorks or similar CAD tools for supporting design and development activities.
• Hands-on experience with research and development activities related to medical devices.
• Ability to train and mentor technicians and operators in prototyping, testing, and process development.
• Experience designing, qualifying, and documenting tooling and fixturing for manufacturing and development.
• Familiarity with developing manufacturing procedures and test or inspection plans to meet quality and regulatory requirements.
• Comfort working in cross-functional teams and building strong collaborative relationships across engineering, operations, and quality.
• Motivation to contribute to innovation and continuous improvement in products and processes.

Work Environment

This role is based in a brand-new facility in Brooklyn Park that features large, modern, and clean production areas, including spacious clean rooms designed to support medical device manufacturing and development activities. Team members work in a collaborative, growth-oriented environment focused on innovation, manufacturing excellence, and improving lives through medical technology. The facility includes an on-site gym that employees and temporary staff can use, supporting health and wellness. Work is performed in a professional technical setting with access to contemporary engineering tools and equipment appropriate for design assurance, verification and validation, and process development activiti

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

The pay range for this position is $38.00 - $45.00/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)

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

This position is anticipated to close on Nov 6, 2026.

This is a fully onsite position in Brooklyn Park,MN.

About Actalent

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.

The company is an equal opportunity employer and will consider all applications withoutregard to race, sex, age, color, religion, national origin, veteran status, disability,sexual orientation, gender identity, genetic information or any characteristic protectedby law.

If you would like to request a reasonable accommodation, such as the modification oradjustment of the job application process or interviewing process due to a disability,please email View email address on ziprecruiter.com for other accommodation options.

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

Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as acondition of employment or continued employment. An employer who violates this lawshall be subject to criminal penalties and civil liability.

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