Sr. Materials Engineer – Extrusion

Medtronic • Beverly, MA

11h • $108,800 - $163,200

About The Position

We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people. We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary. We change lives. Each team member, each day, helps to improve and redefine how the world treats the most pressing health conditions, from heart disease to diabetes. Our industry leadership comes from the passion and ingenuity of our people. That’s who we are. Working alongside one another, we use science, medicine, and a profound understanding of the human body to build extraordinary technologies that can transform lives. We build extraordinary solutions as one team. With one Medtronic Mindset defining how we work. Speed and decisiveness run through our DNA. Diverse perspectives inspire our bold answers to any challenge that comes our way. And we deliver results the right way, breakthrough after patient breakthrough. This life-changing career is yours to engineer. By bringing your ambitious ideas, unique perspective and contributions, you will… Build a better future, amplifying your impact on the causes that matter to you and the world Grow a career reflective of your passion and abilities Connect to a dynamic and inclusive culture that welcomes the challenge of life-long learning

Requirements

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

Responsibilities

• 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
• 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 (subject to IRS earning minimums)
• 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