
Posted 2 days ago
Sr. Materials Engineer – Extrusion
MedtronicSr. Materials Engineer – Extrusion
Requirements
Master’s degree in Mechanical, Materials, or Plastics Engineering, 2 years extrusion process engineering experience, Experience with ISO 9001, ISO 13485, and cGMP, Proficiency in DOE, SPC, FMEA, and IQ/OQ/PQ, Polymer rheological characterization expertise, Test Method Validation (TMV) experience, DMAIC process and root cause analysis
Skills
SolidWorksMinitabSix SigmaISO 13485
About the role
Responsibilities
- Lead process design, development, and material selection for new and improved extruded catheter sub-assemblies
- Manage polymer rheological characterization programs to benchmark melt properties and accelerate material selection
- Coordinate mechanical and chemical property testing of polymers using design software such as SolidWorks
- Execute installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) for new equipment and product changes
- Perform Test Method Validation (TMV) for extrusion processes to ensure accuracy and regulatory compliance
- Utilize Lean Six Sigma methodologies, including DOE, SPC, and FMEA, to drive production improvement projects
- Conduct root cause investigations using the DMAIC process and implement corrective actions for customer complaints
- Author technical specifications and documentation in compliance with ISO 9001, ISO 13485, and cGMP standards
Requirements
- Master’s degree in Mechanical, Materials, Plastics Engineering, or a related engineering field
- Minimum of 2 years of experience as a materials or extrusion process engineer
- Proven expertise in extrusion process engineering and polymer rheological characterization
- Hands-on experience with ISO 9001, ISO 13485, and cGMP regulatory environments
- Proficiency in statistical tools and methodologies including DOE, SPC, FMEA, and Minitab
- Experience with IQ/OQ/PQ protocols and Test Method Validation (TMV)
- Strong background in DMAIC processes and root cause analysis
Benefits
- Comprehensive health, dental, and vision insurance
- 401(k) plan with employer contribution and match
- Paid time off and paid holidays
- Tuition assistance and reimbursement programs
- Employee Stock Purchase Plan
- Life insurance and disability coverage
About the Company
Medtronic is a global healthcare technology leader dedicated to alleviating pain, restoring health, and extending life. We employ a diverse team of over 95,000 passionate people working to solve the world's most challenging health problems through engineering excellence and scientific innovation.
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Medtronic · Beverly
