R&D Engineer II

MedtronicPlymouth, MN
Hybrid

About The Position

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. The Engineer II will support the stents portfolio within Medtronic’s R&D RPM team in the Peripheral Vascular Health Operating Unit through execution of product and process development activities, technical documentation, validation efforts, and cross-functional collaboration. This role is ideal for an engineer who is eager and quick to learn, enjoys hands-on technical work, and is motivated by contributing to projects and teams that directly impact patients. The position is responsible for supporting test method development and validation activities, regulatory submission support, equipment qualification and revalidation efforts, and site operational initiatives. The role requires strong collaboration across functions and hands-on technical engagement to develop a deep understanding of stent therapies, product functionality, and manufacturing processes. U.S. Candidates: This role offers a flexible work style that may include a combination of onsite and remote work. Please note that flexible arrangements are not guaranteed for all positions and may change over time based on business needs and facility space. Future adjustments could include transitioning to full-time onsite.

Requirements

  • Requires a Baccalaureate degree AND minimum of 2 years of relevant experience OR Master's degree with a minimum of 0 years relevant experience
  • Working knowledge of QMS requirements and document control processes
  • Strong technical writing, analytical, and problem-solving skills
  • 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.
  • Roles below the Principal level require candidates to possess unrestricted U.S. work authorization at the time of hire and for the duration of employment.

Nice To Haves

  • 2+ years of engineering experience in medical device, regulated manufacturing, or related industry
  • Familiarity with stent technologies, test methods, equipment qualification, or process validation
  • Experience with validation activities, technical documentation, and regulated quality systems
  • Experience supporting TMVs, PPAPs, IQ/OQ/PQ activities, or equipment validations
  • Hands-on laboratory or manufacturing support experience

Responsibilities

  • Support execution of technical strategies and deliverables for the stents portfolio within the R&D RPM group
  • Execute and support test strategies, including development, coordination, and completion of testing activities
  • Perform hands-on laboratory and product evaluation work to build technical understanding of stent products and associated therapies
  • Develop understanding of product functionality through test methods (TM), technical documentation, and product evaluations
  • Execute Test Method Validations (TMVs) in accordance with applicable procedures and regulatory requirements
  • Support Production Part Approval Process (PPAP) activities and associated documentation requirements
  • Route, review, and approve technical reports while ensuring compliance with Quality Management System (QMS) procedures and documentation standards
  • Collaborate with Regulatory Affairs to understand submission strategies and support regulatory documentation needs
  • Support equipment replacement, qualification, and revalidation activities across the site
  • Develop qualification strategies leveraging lessons learned and best practices from recent equipment validation projects
  • Partner with Subject Matter Experts (SMEs) to support equipment-related projects and technical initiatives
  • Assist with execution of site DOTM (Design/Development Transfer or applicable operational) activities
  • Support cross-functional teams to ensure project timelines, compliance requirements, and operational objectives are achieved
  • Design, develop, analyze, troubleshoot and provide technical skills during research and/or product development
  • Design studies to investigate specific life science questions within field of expertise
  • May be involved in product research and development and/or clinical trials
  • Translate research discoveries into usable and marketable products

Benefits

  • Health, Dental and vision insurance
  • Health Savings Account
  • Healthcare Flexible Spending Account
  • Life insurance
  • Long-term disability leave
  • Dependent daycare spending account
  • Tuition assistance/reimbursement
  • Simple Steps (global well-being program)
  • Incentive plans
  • 401(k) plan plus employer contribution and match
  • Short-term disability
  • Paid time off
  • Paid holidays
  • Employee Stock Purchase Plan
  • Employee Assistance Program
  • Non-qualified Retirement Plan Supplement (subject to IRS earning minimums)
  • Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)
  • Paid sick time (for temporary employees, as required under applicable state law)
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