Sr Reliability Engineer

Medtronic•Lafayette, CO

2d•Onsite

About The Position

Medtronic is seeking a Senior Supplier / Manufacturing Quality Engineer to support the Surgical Operating Unit’s new product development quality team. The role influences product design for manufacturability, inspection, and assembly; works with internal and external suppliers to develop robust manufacturing processes; qualifies processes for sustainable supply; and supports supply and manufacturing continuity through product transfer. It supports medical-device product development and effective design transfer in a regulated environment. The position requires occasional travel to supplier locations in the United States and internationally. The role is expected to be onsite at least four days per week.

Requirements

Bachelor’s degree in engineering or a related technical field and at least 4 years of relevant experience, or an advanced degree and at least 2 years of relevant experience.
Extensive understanding of manufacturing processes for plastics, metals, electronics, and/or product-level assembly.
Extensive understanding of GD&T, FMEA, and DFX principles.
Extensive experience working in a regulated environment.
Strong analytical and problem-solving skills, including the ability to conduct thorough root-cause analysis.
Excellent written and verbal communication skills and ability to collaborate with cross-functional teams and present complex information to stakeholders.
Proven leadership and project management skills, including the ability to lead teams and manage multiple projects simultaneously.
Unrestricted U.S. work authorization at the time of hire and for the duration of employment for roles below Principal level, according to the posting’s sponsorship policy.

Nice To Haves

Certified Quality Engineer (CQE), Six Sigma Green Belt, or equivalent certification.
AAMI design control certification.
In-depth knowledge of FDA regulations, ISO 13485, ISO 14971, and other relevant standards.
Proficiency in quality management systems, risk management, regulatory compliance, and statistics.
Lead auditor experience.
Basic knowledge of human anatomy and physiology and surgical procedures.
Familiarity with SAP, Trackwise, and Windchill or Agile.

Responsibilities

Select and qualify suppliers, ensuring they deliver quality parts, materials, and services.
Monitor parts through the manufacturing cycle and promptly identify and resolve supplier-related problems.
Evaluate suppliers’ technical and manufacturing capabilities against product, process, quality, and business requirements.
Manage Non-Conformance Material Reports (NCMRs) for material, component, and production issues; identify, analyze, and address trends across incoming, production, and sterilization areas.
Manage supplier change requests, including communication, project management, and regular reporting.
Manage the Approved Supplier List, including supplier evaluation, agreements, audits, and acceptance.
Qualify materials through the Production Part Approval Process (PPAP), including process validation, test-method validation, technical writing, and project management.
Improve supplier performance and reduce manufacturing escapes through issue escalation, Supplier CAPA management, and Quality Performance Reviews.
Oversee process validation (IQ/OQ/PQ) and Master Validation Planning in new product development.
Perform statistical analysis of manufacturing process performance outputs.
Oversee Process Failure Mode and Effects Analysis (FMEA), internally and externally.
Collaborate across functions to capture process limitations in design controls, including Design FMEA and Design for Manufacturability and Assembly activities.
Collaborate across functions to identify essential components, product features, and their process controls.
Ensure design transfer translates design specifications effectively into production specifications.
Use project management skills to ensure supplier processes develop on a cadence that supports engineering builds and Design Verification and Validation.
Travel occasionally to visit suppliers in the United States and internationally.

Benefits

Health insurance
Dental insurance
Vision insurance
Health Savings Account
Healthcare Flexible Spending Account
Life insurance
Long-term disability leave
Dependent daycare spending account
Tuition assistance/reimbursement
Well-being program
Incentive plans, including eligibility for the Medtronic Incentive Plan (MIP) short-term incentive
401(k) plan with 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