Principal Equipment Engineer - Fridley, MN

MedtronicFridley, MN
$128,800 - $193,200Onsite

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. A Day in the Life We are currently seeking a recognized technical expert and highly motivated Principal Equipment Engineer to join our Advanced Manufacturing Engineering (AME) Team. The AME Team is a key Operations Unit representative on New Product Development (NPD) core teams for the development and commercialization of new combination devices (device/drug). In this role, you will serve as the subject matter expert for equipment engineering, driving the strategic direction of manufacturing equipment design, procurement, integration, and qualification across large-scale, cross-functional projects. You will exercise considerable latitude in defining deliverables and will coach and guide other engineers to elevate the team's overall capability. At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We’re working a minimum of 5 days a week onsite as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary. This role will require up to 15% of travel annually to enhance collaboration and ensure successful completion of projects.

Requirements

  • Bachelor's degree with a minimum of 7 years of relevant experience OR Master's degree with a minimum of 5 years relevant experience OR PhD with a minimum of 3 years relevant experience.
  • 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.

Nice To Haves

  • Extensive experience working in a regulated environment (e.g., FDA, ISO 13485).
  • Proven project management experience leading large or moderately complex projects with cross-functional teams, including setting roadmaps and managing project pipelines.
  • Deep experience developing and working with User Requirement Specifications (URS), Functional Design Specifications (FDS), GAMP5, and compliance systems.
  • Demonstrated experience managing external Automation vendors end-to-end, including developing user requirements, statements of work, and overseeing execution through completion.
  • Experience designing manufacturing fixturing and tooling using CAD software (e.g., SolidWorks, Creo, or equivalent) to support prototyping, testing, or production activities.
  • Proficiency with additive manufacturing processes, including SLA and FDM 3D printing, for rapid prototyping, fixture development, or concept validation.
  • Ability to review, interpret, and provide direction on equipment schematics in collaboration with vendors.
  • Experience coaching, mentoring, or leading technical teams.
  • Strong negotiation and influencing skills with internal and external stakeholders.

Responsibilities

  • Define and drive the strategic direction for equipment engineering standards, processes, and best practices across multiple product lines and programs, with a significant impact on work group results.
  • Contribute to the definition of new products, processes, standards, and operational plans based on business strategy.
  • Manage large, complex projects or initiatives that span outside of the immediate job area, including delegation and review of work products.
  • Serve as a primary technical contact representing the organization on key projects and initiatives with internal and external customers and vendors at various levels.
  • Experience managing equipment governance reviews, including coordinating cross functional and cross site stakeholders, driving agenda-based discussions, documenting decisions, and defining actions through the equipment procurement and approval lifecycle.
  • Lead the development of clear, detailed, and scalable Equipment Specifications based on process needs, ensuring alignment with long-term manufacturing strategy and regulatory requirements.
  • Identify, analyze, and resolve difficult, moderately complex, and undefined problems through detailed information gathering, data-driven analysis, and investigation.
  • Develop and implement solutions independently that result in moderate to significant improvements to processes, systems, or equipment performance.
  • Prepare design specifications, technical analyses, and strategic recommendations for presentation and approval to leadership and cross-functional stakeholders.
  • Oversee and lead Equipment Qualification activities to ensure compliance, efficiency, and alignment with project goals.
  • Perform and guide Test Method Validation and Equipment Characterization efforts.
  • Utilize advanced Statistical Tools to analyze equipment performance, identify trends, and drive continuous improvement.
  • Develop, refine, and standardize Manufacturing Procedures and Set-up Procedures to ensure consistent and scalable application.
  • Define and drive best practices around Automation equipment design principles, software change control, and process control.
  • Collaborate with Engineering during early design phases to provide strategic input and design options for Manufacturing Automation.
  • Partner with and influence internal stakeholders across Operations, Quality, and Engineering to ensure alignment on objectives, strategy, and goals.
  • Lead collaboration with external Automation partners during build, development, testing, and validation of Automation equipment, including negotiation and decision-making influence.
  • Provide post go-live hypercare support and ensure flawless deployment of equipment and systems.
  • Oversee and define Preventive Maintenance (PM) and Calibration strategies for equipment.
  • Provide guidance, coaching, and training to other engineers and specialists within the equipment engineering job area.
  • Review and delegate work to lower-level specialists, acting as a team leader on major projects.
  • Foster a culture of technical excellence and continuous learning within the team.

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)
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