Senior Manufacturing Engineer - Injection Molding Focus

Medtronic • North Haven, CT

8d • Onsite

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)

What This Job Offers

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