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Sr. Design Assurance Engineer

1 month ago

Minneapolis, United States Actalent Full time
Description:
The Senior Design Assurance Engineer is a quality engineer that directly supports medical device product development from concept through commercialization working with cross-functional development teams to establish and maintain the design control deliverables, risk management activities, and DHF compliance to ensure delivery of the highest quality product to the customer.
Essential Functions:
•Create and ensure on-time execution of Quality Plans for internal development, OEM-based, Clinical Product Development (CPDP), and design change projects and leading on-time completion of protocols, reports and assigned project deliverables
•Accountable for Design Verification and Validation planning and /or, including active cross-functional root-cause analysis investigation & resolution activities
•Lead Risk Management activities from product Concept through Commercialization
•Support design test and inspection method development, and lead method validation activities
•Ensure DHF content integrity, completeness, and regulatory / standards compliance; collaboratively communicating & resolving gaps
•Support and ensure internal & external audit responses and on-time product re-certifications
•Support and ensure the establishment of objective, measurable, discrete, and verifiable customer, and product requirements
•Support and ensure objective component specification definitions, supplied component sampling plan development, and vendor qualifications
•Provide support for biocompatibility and sterilization qualifications
•Develop and lead other team members and provide work direction as required
•May have 2-3 technicians assigned for inspection, testing and project support
•Performs other functions as required
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.