Design Assurance EngineerJob DescriptionThe Design Assurance Engineer is a quality engineer who directly supports medical device product development from concept through commercialization. This role involves working with cross-functional development teams to establish and maintain design control deliverables, risk management activities, and DHF compliance, ensuring the delivery of the highest quality product to the customer.Responsibilities:
Will be working with FDA regulations regarding design verification and validation planning.
Will be performing risk management activities, design tests and inspection method development.
Performing audit responses and product re-certifications, biocompatibility and sterilization support.
Work with vendors, supplied component sampling plan development, and objective component specifications.
Qualifications:
BS Industrial Engineering, Engineering or Business Degree
8-15 years of medical device experience in Quality Operations, or equivalent experience
Must have FDA regulations knowledge within industry
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 [email protected] (%[email protected]) for other accommodation options.