Senior Manufacturing Engineer - Injection Molding Focus

Overview

Senior Manufacturing & Injection Molding Engineer responsible for the end‑to‑end lifecycle of finished devices, including bioabsorbable components, within an ISO 13485/FDA regulated cleanroom environment.

• Establish, optimize, and document robust, repeatable injection molding processes utilizing scientific molding principles and DOE.
• Manage strict process controls for bioabsorbable resins, minimizing IV loss, controlling residence time and preventing thermal degradation.
• Lead DFM reviews for complex, multi‑cavity, and micro‑molding tools, partnering with toolmakers to oversee mold construction, modifications, and resizing.
• Work with manufacturing and quality teams daily to review and disposition production defects, providing corrective actions to meet schedules and quality expectations.
• Review field returns, determine root causes, and develop effective corrective actions.
• Create engineering studies and validation documentation (Bill of Materials, DOE, statistical validity) for accuracy and compliance.
• Serve as lead engineer for molding and automated assembly equipment design specifications, vendor selection, design reviews, FAT, SAT, and validation.
• Lead capacity expansion and process improvement projects to increase yields, reduce scrap, and improve product quality.
• Author SOPs, design manufacturing fixtures, and train operators and technicians on new production lines.
• Execute comprehensive validation protocols (IQ/OQ/PQ) for molding machines, automated and manual assemblies, and multi‑cavity molds in compliance with FDA 21 CFR Part
  820.
• Lead risk assessment activities, including creation and maintenance of PFMEAs.
• Conduct root‑cause investigations for production anomalies and manage NCR and CAPA execution.

• Bachelor’s degree with a minimum of 4 years of relevant experience, or Master’s with a minimum of 2 years, or PhD with no prior experience.
• Proven track record with bioabsorbable or resorbable polymers (PLA, PLGA, PGA).
• Experience with GD&T, PFMEA, and statistical process control (SPC) using Minitab.
• Solid knowledge of ISO
  13485, ISO
  14644 cleanroom standards, and FDA medical device regulations.
• Strong presentation, computer (Excel, Word, PowerPoint, AutoCAD, Solid Works) and project‑management skills.
• Self‑motivated, able to multitask in a fast‑paced environment, and excellent interpersonal communication.
• For Baccalaureate degrees earned outside the United States, certification to satisfy 8C.F.R. §214.2(h)(4)(iii)(A) is required.

• 3‑4 years of regulated injection molding experience.
• Advanced degree in Plastics Engineering, Polymer Engineering, Manufacturing Engineering, or Mechanical Engineering.
• Experience with mold operation, design, maintenance, mold‑flow analysis, and automated machine design.

Position requires regular independent mobility, computer use, and communication with coworkers. Reasonable accommodations may be provided for individuals with disabilities. The specific demands are described in the responsibilities section of this job description.

• Salary range: $ – $ (USD) for U.S. locations (excluding Puerto Rico).
• Short‑term incentive plan (MIP).
• Health, dental, vision insurance;
  Health Savings Account;
  Flexible Spending Account.
• Life insurance, long‑term disability leave, dependent daycare spending account, tuition assistance.
• 401(k) plan with employer contribution and match; short‑term disability; paid time off; paid holidays.
• Employee Stock Purchase Plan;
  Employee Assistance Program; non‑qualified retirement plan supplement.

It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status or any other characteristic protected by federal, state or local law.

In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.