Sr Reliability Engineer

Medtronic•Lafayette, CO

3d•$107,200 - $160,800•Onsite

About The Position

Medtronic is seeking a Senior Supplier / Manufacturing Quality Engineer for its Surgical Operating Unit new product development quality team. The role influences product design for manufacturability, inspection, and assembly; works with internal and external suppliers to develop robust processes; qualifies manufacturing processes; and helps maintain sustainable supply and manufacturing continuity until product transfer. The position supports medical device product development and successful design transfer, with emphasis on manufacturing processes, process development and controls, process validation, supplier management, and regulatory compliance. The role requires occasional travel to suppliers within the United States and internationally. Medtronic requires employees to work onsite at least four days per week. The position is eligible for the Medtronic Incentive Plan. The advertised U.S. salary range, excluding Puerto Rico and certain California locations, is $107,200 to $160,800.

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 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.

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/physiology and surgical procedures.
Experience with SAP, Trackwise, Windchill, or Agile.

Responsibilities

Select and qualify suppliers, ensuring they deliver quality parts, materials, and services.
Monitor parts through the manufacturing cycle and identify and resolve supplier-related problems.
Evaluate supplier technical and manufacturing capabilities against product, process, quality, and business requirements.
Manage Non-Conformance Material Reports for material, component, and production issues, identifying, analyzing, and addressing 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 for new product development.
Perform statistical analysis of manufacturing process performance outputs.
Oversee Process Failure Mode and Effect Analysis internally and externally.
Collaborate across functions to capture process limitations in design controls, including Design Failure Mode and Effects Analysis 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 schedule to support engineering builds and Design Verification and Validation.
Travel occasionally to visit suppliers in the United States and internationally.