This role pays less than
83%
of similar roles. Most pay
$137,000–$174,375
— the shaded band above.
At the midpoint, this role pays about
$123k
versus about
$156k
for comparable roles.
Based on 240 similar postings.
Employer
About Medtronic
Medtronic plc is the world's largest medical technology company by revenue, specializing in device-based therapies for over 70 health conditions.
Medtronic currently has
58 open roles
on FindRole.
Listed pay typically runs
$118,400–$177,600
across 55 roles with salary data.
The New Product Development Senior Supplier Quality Engineer joins the Surgical Operating Unit to influence design based on manufacturability, inspection, and assembly while ensuring robust manufacturing processes for medical devices. This role involves managing supplier selection, qualification, and performance through the Production Part Approval Process (PPAP), including process validation and technical writing. You will manage non-conformance reports, oversee process failure mode and effect analysis, and ensure design specifications translate effectively into production requirements. The position requires expertise in manufacturing processes for plastics, metals, electronics, and assembly, alongside proficiency in GD&T, DFX principles, and statistical analysis. Key tools include SAP, Trackwise, Windchill, and Agile. You will navigate a regulated environment governed by FDA regulations, ISO 13485, and ISO 14971 to ensure manufacturing continuity and quality for critical medical components during the transition from development to production.
Select and qualify suppliers while ensuring they deliver high-quality parts, materials, and services.
Manage Non-Conformance Material Reports (NCMRs) by identifying trends and resolving issues across production areas.
Oversee process validation activities including IQ/OQ/PQ and Master Validation Planning for new products.
Perform statistical analysis of manufacturing performance and conduct Failure Mode and Effect Analysis (FMEA).
Manage supplier change requests, audits, and the Approved Supplier List to ensure supply continuity.
Qualify materials through the Production Part Approval Process (PPAP) including test method validation and technical writing.
Coordinate with cross-functional teams to ensure design specifications are accurately translated into production requirements.
Drive supplier performance improvements by managing Corrective and Preventive Actions (CAPA) and quality reviews.
What we're looking for
Bachelor's degree in engineering or a related technical field with at least 4 years of experience, or an advanced degree with at least 2 years of experience.
Extensive understanding of manufacturing processes for plastics, metals, electronics, and product assembly.
Extensive knowledge of GD&T, FMEA, and DFX principles.
Extensive experience working in a regulated environment.
Strong analytical skills to perform root cause analysis and solve complex problems.
Excellent written and verbal communication skills for cross-functional collaboration and stakeholder reporting.
Proven leadership and project management skills to manage multiple projects simultaneously.
Work authorization at the time of hire and for the duration of employment.
GMP
ISO 13485
21 CFR Part 820
Root Cause Analysis
New Product Development (NPD)
Process Validation
Design Transfer
Supplier Audit
Risk Assessment
Technical Documentation
Continuous Improvement
AS9100
ISO 9001
FMEA
RCCA
8D
APQP
PPAP
GD&T
Statistical Process Control
Quality Management Systems
Metrology
Electro-mechanical Design
Data Analysis
Manufacturing Processes
AS9100
ISO 9001
FMEA
RCCA
8D
APQP
PPAP
GD&T
Statistical Process Control
Quality Management Systems
Metrology
Electro-mechanical Design
Data Analysis
Manufacturing Processes