Senior Manufacturing Engineer - Injection Molding Focus
About The Position
This specialized Senior Manufacturing & Injection Molding Engineer role bridges advanced plastics processing with regulated medical device manufacturing. This position owns the entire lifecycle of finished devices which includes bioabsorbable components — from initial tooling design and scientific process development to component assemblies, equipment qualification, and final packaging. A critical differentiator for this role is deep technical expertise in handling highly sensitive absorbable/bioresorbable polymers (such as PLA, PGA, and PLGA) within an ISO 13485 / FDA-regulated cleanroom manufacturing environment. At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We’re working a minimum of 5 days a week onsite as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary.
Requirements
- Bachelor's degree with a minimum of 4 years of relevant experience OR Master's degree with a minimum of 2 years relevant experience OR PhD with 0 years relevant experience.
Nice To Haves
- Minimum of 3–4 years of injection molding experience, preferably in a regulated manufacturing environment, highly preferred.
- Bachelor’s or advanced degree in Plastics Engineering, Polymer Engineering, Manufacturing Engineering, or Mechanical Engineering.
- Proven track record working with bioabsorbable or resorbable polymers (PLA, PLGA, PGA) is highly preferred.
- Demonstrated knowledge of GD&T and PFMEA.
- Significant Plastics manufacturing process experience, Mold Operation, Mold design, Mold Maintenance, Mold Flow analysis, Experience in automated machine design, repair, and troubleshooting.
- Solid presentation and computer skills (Excel /Word / PowerPoint/ Projects/ AutoCAD/ SolidWorks, etc.)
- Strong background in Statistical Process Control (SPC), Minitab, and data analysis to evaluate process capability (Cpk).
- Project management skills to keep projects on track
- Self-motivated attitude with the ability to multitask and thrive in a fast-paced environment
- Excellent Interpersonal communication skills
- Solid working knowledge of ISO 13485, ISO 14644 (cleanroom standards), and FDA medical device manufacturing regulations.
- For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.
Responsibilities
- Establish, optimize, and document robust, repeatable injection molding processes utilizing Scientific Molding principles and Design of Experiments (DOE).
- Manage strict process controls tailored to bioabsorbable resins.
- Optimize parameters to minimize Inherent Viscosity (IV) loss, strictly control material residence time, and prevent thermal degradation.
- Lead Design for Manufacturability (DFM) reviews for complex, multi-cavity, and micro-molding tools.
- Partner with toolmakers to oversee mold construction, modifications, and steel resizing.
- Team with manufacturing and quality personnel on a daily basis to review / disposition production defects and provides potential process and/or equipment corrective actions to assure production schedules and quality expectations are met.
- Review product field returns to determine root cause of potential manufacturing defects then develop and implement effective corrective actions.
- Create and execute engineering studies, DOE, Bill of material updates, and validation documentation for accuracy, statistical validity, and compliance.
- Served as lead engineer for molding and automated assembly equipment design specifications, request for quotes, vendor selection activities, equipment design review, FAT, SAT, and validation activities.
- Lead Capacity Expansion and Process Improvement Projects to increase yields, reduce scrap, and Improve Product Quality
- Author standard operating procedures (SOPs), design custom manufacturing fixtures, and train operators and technicians on new production lines.
- Author and 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 the creation and maintenance of PFMEAs.
- Conduct root-cause investigations for production anomalies, owning the execution of Non-Conformance Reports (NCR) and Corrective and Preventive Actions (CAPA).
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)
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What This Job Offers
Job Type
Full-time
Career Level
Senior
