This role pays less than
63%
of similar roles. Most pay
$179,875–$267,050
— the shaded band above.
At the midpoint, this role pays about
$196k
versus about
$223k
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
46 open roles
on FindRole.
Listed pay typically runs
$130,400–$195,600
across 46 roles with salary data.
The Engineering Manager oversees the design, development, and technical quality assurance for new medical device products. This role involves managing extrusion and assembly manufacturing processes while ensuring compliance with critical industry regulations including 21 CFR Part 820, ISO 13485, EU MDR, SOTA, and GMP. The manager is responsible for personnel selection, risk assessments such as PHA, PFMEA, and ISO 14971, and managing non-conformances, complaints, and CAPA actions. Day-to-day tasks involve utilizing process improvement tools like DMAIC, Root Cause Analysis, 5Whys, Fishbone, and cause mapping. The role also requires executing Design of Experiments (DOE) for process development, performing statistical analysis using Minitab, and managing product validations including IQ, OQ, and PQ. This position solves complex manufacturing challenges to ensure medical device components meet strict technical specifications and safety standards.
What does a Engineering Manager earn?
Median $254300 from 143 postings across 46 companies.
Plan, direct, and implement the design and development of new medical device products.
Maintain technical quality assurance and control systems for extrusion and assembly manufacturing.
Manage risk assessments including PHA, PFMEA, and ISO 14971 standards.
Oversee non-conformances, complaints, and Corrective and Preventive Actions (CAPA).
Utilize DMAIC, Root Cause Analysis, and other process improvement tools to optimize production.
Execute product validations including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
Perform statistical analysis using Minitab and Design of Experiments (DOE) for process development.
Select, develop, and evaluate personnel to ensure efficient departmental operations.
What we're looking for
Master’s degree in Mechanical, Industrial, or Biomedical Engineering and three years of experience as a quality/validation engineer for medical devices.
Bachelor’s degree in Mechanical, Industrial, or Biomedical Engineering and five years of experience as a quality/validation engineer for medical devices.
Three years of experience with extrusion and assembly manufacturing.
Three years of experience with 21 CFR Part 820, ISO 13485, EU MDR, SOTA, and GMP regulations.
Three years of experience with risk management including PHA, PFMEA, and ISO 14971.
Three years of experience managing Non-Conformances, Complaints, and Corrective and Preventive Actions (CAPA).
Three years of experience with process improvement tools like DMAIC, RCA, 5Whys, Fishbone, and cause mapping.
Three years of experience with DOE methods, Minitab statistical analysis, and IQ/OQ/PQ product validation.
Risk Management
ISO 13485
ISO 14971
DFMEA
Root Cause Analysis
Design Controls
Quality Management Systems
Statistical Processes
Requirements Management
Six Sigma
Project Management
ISO 13485
ISO 14971
GMP
CAPA
Lean Manufacturing
Six Sigma
Minitab
Microsoft Excel
Power BI
Electrical Schematics
Statistical Analysis
Continuous Improvement