Medtronic

Medtronic

Principal Design Assurance Engineer

Mounds View, Minnesota, United States of America · Principal · Contract

Sponsorship not specified$132k-$198kDetected 5 days ago
Data AnalysisComplianceProject ManagementProcess ImprovementMechanical DesignGMPFDA RegulatoryMedical DevicesLeadershipCommunicationCollaborationProblem SolvingRegulatory Affairs

About the role

  • We anticipate the application window for this opening will close on - 31 Jul 2026 Careers that change lives start here.
  • Join a diverse team of innovators who bring their worldview, their unique backgrounds, and their individual life experiences to work every day.
  • In-person exchanges are invaluable to our work.

Responsibilities

  • Lead Design Assurance activities across full product cycle in alignment with the overall project phase and project target milestones
  • Own des i gn verification activities, ensuring test strategy and plans aligned with design inputs
  • Li a ise w ith R &D a nd act as the design assu rance SME for d esign v alidati on and h uman fact ors strategies
  • Build strong partnerships across Systems, Software, Hardware, Mechanical Engineering, Clinical, Regulatory Affairs, and Manufacturing to deliver complex technical milestones
  • E xhibit strong problem-solving skills, lead and support project investigations as needed
  • Q uality le ad for any mechanic al de s i gn support r equired including suppor ting design updates and mechanical design reviews
  • Work through extended team members and partner with test lab s to facilitate timely completion of design verification activities in alignment with the overall project phase and project target milestones
  • Lead a skilled team and collaborate with world-class experts across multiple disciplines
  • Partner with cross-functional teams to ensure traceability between design requirements, risk management and design verification test strategy
  • Leadership growth: Lead a skilled team and collaborate with world-class experts across multiple disciplines

Requirements

  • While performing the duties of this job, the employee is regularly required to be independently mobile.
  • The employee is also required to interact with a computer, and communicate with peers and co-workers.

Nice to have

  • Familiarity with these regulations: FDA 21 CFR Part 820 cGMP, ISO 13485, ISO 14971:2019
  • Experience in management of complex data sets and statistical data analysis
  • Practical knowledge of project management
  • Must Have (Minimum Requirements):
  • Bachelor's degree in science, technology, engineering, math or related technical field with a m inimum of 7 years of technical experience OR
  • A dvanced degree in science, technology, engineering, math or related technical field with a minimum of 5 years of technical experience
  • Strong understanding of design control principles
  • For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.

Compensation

  • and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others).

Benefits

  • Impact that matters: Contribute directly to the development of life-saving medical devices in a novel and innovative and growing market sector

Company info

  • Join a team where your work not only challenges you technically but also makes a real difference in patients' lives worldwide
  • As part of ongoing professional development, you will maintain expert, up to date knowledge of developments in regulatory compliance requirements for product design, development, transfer, and commercialization activities

Equal opportunity

  • Medtronic benefits and compensation plans
  • It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law.
  • In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.
  • If you are applying to perform work for Medtronic, Inc. ("Medtronic") in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find here a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment.

Visa & Work Authorization

  • U.S. Work Authorization & Sponsorship
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This listing is sourced directly from Medtronic's careers page and normalized into a canonical job model.