Principal Manufacturing Molding Engineer

Abbott • Scarborough, ME

11d • $99,300 - $198,700 • Onsite

About The Position

The Principal Manufacturing Molding Engineer position is part of Abbott's Infectious Disease Developed Markets business unit and is based in Scarborough, Maine. This role is responsible for leading manufacturing equipment initiatives, driving quality, efficiency, and cost-saving improvements, optimizing materials and molding processes, reducing manufacturing costs, and providing engineering support for new product development and commercialization efforts.

Requirements

• Bachelor's degree (BS) in Plastics Engineering, Mechanical Engineering or equivalent combination of education and experience.
• 10+ years’ engineering experience in a regulated manufacturing environment, preferably in medical devices.
• Technical experience in mechanical or plastics engineering.
• Experience with change management principles and practices.
• Proficient in the application of lean six sigma principles and the DMAIC approach or other systemic problem-solving processes.
• Experience interacting with various suppliers in a technical consulting capacity
• Experience in Microsoft Suites software. (Microsoft Excel, PowerPoint, Power BI, etc.) as well as Minitab and CAD software.

Nice To Haves

• Prior experience working in a company operating under ISO, FDA, or similar quality systems or regulations.
• Experience with cGMP and ISO 13485 regulations and practices.
• Experience with statistical analysis software. (Minitab or JMP preferred)
• Experience in injection molding of medical devices.

Responsibilities

• Lead end-to-end injection molding and mold tooling projects, ensuring on-time delivery, budgeting, cost control, and cross-functional alignment for programs
• Design, develop, validate, and optimize mold tooling, and injection molding processes to maximize quality, compliance, yield, and efficiency.
• Apply scientific injection molding, DOE, capability studies, root cause analysis, and IQ/OQ/PQ validation to establish robust processes.
• Troubleshoot complex injection molding, mold tooling, quality, and production issues to retain quality, optimize cost, reduce scrap, variability, and downtime.
• Lead and document mold tooling manufacturing from design through first lot to stock. Activities, including yet not limited to budget management, design reviews, supplier mold tooling build activities, FATs, mold corrections, dimensional analysis, and qualification efforts.
• Support NPI and manufacturing transfers from concept through scale-up, commercialization, and global production deployment.
• Partner with strategic suppliers and internal cross functional teams to manage mold tooling, materials, capacity, quality, cost, and lifecycle improvements.
• Establish process standards, control plans, FMEAs, DFM practices, and compliance with regulatory, ISO, and quality system requirements.
• Evaluate and implement advanced molding technologies, automation, equipment, and capital investments to improve performance and reduce costs.
• Provide technical leadership and mentoring in mold making, tooling design, plastics processing, and continuous improvement initiatives.
• Lead supplier engineering and manufacturing support activities, including process validation, design for manufacturability (DFM), material selection, process development, molding asset management, and supplier capability improvement to ensure robust, compliant production.
• Drive technical risk management and problem resolution by leading failure investigations, root cause analysis, CAPA activities, FMEA development, and design reviews while ensuring design intent, product specifications, and regulatory requirements are met.
• Provide plastics and manufacturing subject matter expertise for product development, raw material qualification, process characterization, tooling development, validation, and engineering change management, including Agile PDM-controlled changes.
• Advance operational excellence through continuous improvement and cost reduction initiatives, evaluating manufacturing processes, materials, equipment, and supplier performance to improve quality, efficiency, reliability, and overall product value.
• Support cross-functional engineering strategy and talent development by collaborating with quality, project management, operations, and external suppliers, while mentoring engineers and technicians, developing technical documentation, and maintaining compliance with FDA, ISO, and company quality systems.

Benefits

• Career development with an international company where you can grow the career you dream of.
• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• An excellent retirement savings plan with a high employer contribution
• Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.
• A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune.
• A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists.

What This Job Offers

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