Senior Design Assurance Engineer

Manpower Engineering is currently partnering with a twin cities start-up medical device company focused on a novel transcatheter product for heart valve disease that will change the future of treatment for patients across the world. The Senior Design Assurance Engineer is a key member on a team of engineers, playing a vital role in product development activities and providing expertise to cross-functional project team members including Project Management, Quality Assurance, Research & Development, and Regulatory Affairs

Job Title: Senior Design Assurance Engineer

Location: Plymouth, MN

Pay Range: $110-125K

Whats the Job?

• Define and refine design requirements, risk controls, and develop test methodologies to assure they meet defined requirements and risks have been mitigated (dFMECA).
• Engage in design control activities according to ISO 13485, FDA 21 CFR Part 820.30 and standard operating procedures (SOPs).
• Drive improvements to risk management activities including risk management plans, hazard analyses, pFMEAs, and use related risk assessments prior to pivotal execution.
• Drive improvements to risk management, documentation, equipment/calibration, and supplier management system(s) in pursuit of ISO 13485 certification.
• Participate in the creation of specifications for components, assemblies, finished products, packaging and labelling and identify the quality-critical attributes for products and processes.
• Review design verification and design validation plans, protocols, and reports ensure that products meet design inputs and user needs according to their intended use.

Whats Needed?

• Bachelors degree in mechanical or biomedical engineering, science, quality assurance, or related field.
• A minimum of four (4) years of experience in class II or class III medical device product development, preferably intravascular devices.
• Proven understanding of ISO 13485, ISO 14971, and FDA QSRs regulations.
• Strong statistics knowledge and experience.
• Verbal and written communication skills sufficient to plan and coordinate work, write detailed work instructions.

If this is a role that interests you and youd like to learn more, click apply now and a recruiter will be in touch with you to discuss this great opportunity. We look forward to speaking with you!

About ManpowerGroup, Parent Company of: Manpower, Experis, Talent Solutions, and Jefferson Wells

ManpowerGroup (NYSE: MAN), the leading global workforce solutions company, helps organizations transform in a fast-changing world of work by sourcing, assessing, developing, and managing the talent that enables them to win. We develop innovative solutions for hundreds of thousands of organizations every year, providing them with skilled talent while finding meaningful, sustainable employment for millions of people across a wide range of industries and skills. Our expert family of brands Manpower, Experis, Talent Solutions, and Jefferson Wells creates substantial value for candidates and clients across more than 75 countries and territories and has done so for over 70 years. We are recognized consistently for our diversity - as a best place to work for Women, Inclusion, Equality and Disability and in 2022 ManpowerGroup was named one of the World's Most Ethical Companies for the 13th year - all confirming our position as the brand of choice for in-demand talent.