Sr. Materials Engineer – Extrusion

Medtronic • Beverly, MA

2d

About The Position

Responsible for process design, development, and material selection to support new and improved extruded catheter sub-assemblies; perform and maintain polymer rheological characterization program to shorten material selection process and benchmark melt properties; coordinate Mechanical as well as Chemical property testing of polymer through the use of design software to include SolidWorks, etc.; order, implement and perform installation qualification (IQ), operational qualification (OQ) and performance qualification (PQ) on new equipment, new products and existing product changes for tooling design and development; execute Test Method Validation (TMV) activities for extrusion processes, ensuring accuracy, repeatability, and compliance with industry standards; review new applications to leverage existing technologies; provide Process Engineering support and direction for development runs and potential problems for manufacturing of medical devices; present extrusion concerns at Material Review Board meetings; deploy Lean Six Sigma methodology using methods including Design of Experiments (DOE), Statistical Process Control (SPC), Failure Mode Effects Analysis (FMEA), and FDA Quality System Regulations (QSR) to solve and implement production improvement projects in extrusion; perform data analysis with Minitab; author and institute written technical specifications through document control systems for new and existing process, as required under ISO 9001, ISO 13485 and Current Good Manufacturing Practices (cGMP); collaborate with Quality and leveraging DMAIC process in root cause investigation and implement corrective actions for customer complaints; and collaborate with overseas customers regarding process changes. Relocation assistance is not available for this position. #LI-DNI.

Requirements

• Master’s degree in Mechanical, Materials, or Plastics Engineering or related engineering field
• Two (2) years of experience as a materials or extrusion process engineer or related occupation
• At least two (2) years of experience with Extrusion process and project engineering
• At least two (2) years of experience with ISO 9001, ISO 13485, and cGMP
• At least two (2) years of experience with DOE, SPC, FMEA, QSR, IQ/OQ/PQ, and technical writing
• At least two (2) years of experience with Test Method Validation
• At least two (2) years of experience with polymer rheological characterization
• At least two (2) years of experience with Mechanical & Chemical property testing of polymer
• At least two (2) years of experience with DMAIC process, root cause analysis, and implementation of corrective action

Nice To Haves

• Experience with SolidWorks

Responsibilities

• Process design, development, and material selection for extruded catheter sub-assemblies
• Perform and maintain polymer rheological characterization program
• Coordinate Mechanical and Chemical property testing of polymer
• Order, implement, and perform IQ, OQ, and PQ on new equipment, products, and existing product changes
• Execute Test Method Validation (TMV) activities for extrusion processes
• Review new applications to leverage existing technologies
• Provide Process Engineering support and direction for development runs and manufacturing of medical devices
• Present extrusion concerns at Material Review Board meetings
• Deploy Lean Six Sigma methodology (DOE, SPC, FMEA, QSR) for production improvement projects
• Perform data analysis with Minitab
• Author and institute written technical specifications for new and existing processes
• Collaborate with Quality on root cause investigation and corrective actions for customer complaints
• Collaborate with overseas customers regarding process changes

Benefits

• Health, Dental and vision insurance
• Health Savings Account
• Healthcare Flexible Spending Account
• Life insurance
• Long-term disability leave
• Dependent daycare spending account
• Tuition assistance/reimbursement
• Simple Steps (global well-being program)
• Incentive plans
• 401(k) plan plus employer contribution and match
• Short-term disability
• Paid time off
• Paid holidays
• Employee Stock Purchase Plan
• Employee Assistance Program
• Non-qualified Retirement Plan Supplement
• Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)

What This Job Offers

• Job Type: Full-time
• Career Level: Senior