myGwork - LGBTQ+ Business Community · 2 days ago

Senior Design Quality Assurance Engineer

Arden Hills, MN

Full-time

Hybrid

Senior Level

5+ years exp

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Responsibilities

Promotes Cross-Functional collaboration and has ability to influence project strategy. Capable of working independently on highly specialized projects with long range objectives.

Provide quality and compliance input and coaching for product development and/or post market product sustaining activities, such as design changes, product CE marking, customer complaint investigations, AI requests, NCEP’s and CAPA’s.

Exercises considerable latitude in determining technical objectives of assignments. Selects methods and techniques to lead a project to completion with focus on translating organizational strategy into tactical deliverables.

Provides project direction, coaching, and mentoring for engineering and technical team personnel.

Develops solutions to complex and diverse technical problems which require the regular use of ingenuity and creativity. Exercises judgment within broadly defined practices and policies in selecting methods, specialized techniques, and evaluation criteria for obtaining results.

Proactively investigates, identifies, and implements best-in-class Quality Engineering practices. Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.

Supports internal and external regulatory audits.

Provides technical leadership to business units. Advises management on potential improvements or enhancement to quality systems and processes.

Support development, implementation, and training of corporate quality initiatives.

Qualification

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Medical device engineeringFDA regulationsISO standardsEU MDR regulationsQuality requirementsProduct developmentDesign controlsProduct risk managementTechnical writingCommunicationPresentation

Required

BS in Electrical Engineering, Mechanical Engineering or related degree.

5 years of medical device engineering experience.

Familiar with the FDA, ISO, EU MDR and the medical device industry quality requirements associated with product development, design controls, and product risk management.

Strong communication and presentation skills.

Solid technical writing skills.

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