Be an early applicantLess than 25 applicantsPosted by Agency
Apex Systems · 2 days ago
Design Assurance Engineer
Maple Grove, MN
Full-time
Onsite
Senior Level
$40/hr - $50/hr
3+ years exp
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Responsibilities
Support the execution and documentation of Design Validation & Verification and Usability activities.
Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
Work within a cross-functional team to identify and implement effective controls and support product development from concept through commercialization.
Develop, update, and maintain Design History File and Design Input / Output documentation (Product Specification and Component Specifications).
Update and maintain product risk management tools (i.e. Hazard Analysis, Fault Tree, FMEAs).
Lead and support cross-functional root-cause analysis investigation and resolution activities.
Evaluate and support design test and inspection method development, and lead method validation activities.
Support regulatory submissions to notified bodies.
Demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
Qualification
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Required
Bachelor’s degree in Mechanical Engineering, Biomedical Engineering or related field of study
3+ years of experience in design assurance, quality, new product development, or related medical device / regulated industry experience
Problem solver, capable of facilitating the problem-solving process
Adaptable and effective collaborator in a team environment and in self-directed work
Strong communication skills (verbal & written)
Ability to work in a highly matrixed and geographically diverse business environment
Demonstrated use of Quality tools/methodologies
Benefits
Comprehensive benefits package
Company
Apex Systems
Apex Systems, a division of On Assignment, provides organizations with IT staffing solutions to address gaps in their current workforce.
1,001-5,000 employees
H1B Sponsorship
Apex Systems has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Trends of Total Sponsorships
2023 (43)
2022 (47)
2021 (42)
2020 (85)
Funding
Current Stage
Late StageLeadership Team
Roger Wahman
Chief Technology Officer - SVP
Andrea Schiola
Global Head of Technology Partnerships, SVP, Principal
Recent News
2024-05-21
2024-04-19
Company data provided by crunchbase
