Job Title: Design Assurance Engineer
Job Description

Support the Quality Management System (QMS) organization. Work with design and manufacturing teams, completing operations quality activities. Assignments include use of quality engineering concepts including, but not limited to, design control, process control, risk management, supplier quality, root cause analysis, statistical analysis, and continuous improvement activities. Ensure desired design and product performance requirements are met in compliance with applicable regulatory, customer, and internal requirements. Skills in other technical areas such as verification testing, and sterilization validation are desired. Engage in routine daily activities such as First Article Inspections (FAI), CAPA, NCMR, change order review, and training.

ResponsibilitiesFunction as the operation’s quality representative during the execution of engineering projects.Ensure product development projects and changes to existing products are conducted in compliance with the Quality System Regulations.Conduct NCMR and CAPA investigation and reports, including assisting in troubleshooting manufacturing problems and ensuring requirement compliance.Collaborate with suppliers on NCMRs and supplier CAPAs.Participate in cross-functional teams for the review and disposition of nonconforming products or components.Develop and assist in maintenance of Product Risk Management Files (Risk Management Plan, Risk Assessments, DFMEA, PFMEA, and Risk Management Report).Prepare and review documentation with a high degree of accuracy, completeness, and effectiveness.Participate in the development of Design Verification and Validation test plans/protocols and Process Verification and Validation test plans/protocols. Provide guidance on Product Requirements compliance.Provide guidance and direction for sample size and statistical analysis of Verification and Validation testing.Participate in Design Reviews and FMEA Reviews.Participate in complaint investigation and ensure investigations are thoroughly documented.Provide direction to project teams on all Quality Policies/Procedures (including verification, validation, statistical methods, and design controls), when necessary.Essential SkillsBackground in quality assurance, including quality systems, standards, metrics, and tools.Working knowledge in medical device products and ISO13485 standards.Experience in new product design/development, design assurance, quality engineering, and new product development.Proficiency in design control, design, Solidworks, root cause analysis, process development, R&D, ISO, quality system, risk management, PFMEA, process validation, GD&T, and CAPA.5+ years of experience in a related field.Additional Skills & QualificationsSkills in other technical areas such as verification testing and sterilization validation are desired.Work Environment

We are a contract manufacturer offering medical device prototyping, development, and manufacturing. Our primary capabilities are balloon catheters, delivery systems, reinforced and steerable catheters, nitinol components, and biomedical textiles.

Pay and Benefits

The pay range for this position is $53.00 - $60.00/hr.

Workplace Type

This is a fully onsite position in Minneapolis,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 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

Hiring diverse talent Maintaining an inclusive environment through persistent self-reflection Building a culture of care, engagement, and recognition with clear outcomes Ensuring growth opportunities for our people

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 actalentaccommodation@actalentservices.com for other accommodation options.