Principal Manufacturing Molding Engineer

The Role

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.

What You’ll Work On

• 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
• 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
• 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

Required Qualifications

• 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

PREFERRED QUALIFICATIONS

• 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

Competencies

• Technical Competencies : Injection Molding, Tooling Design, Part Design, Qualification or Validation, CAD, Industry Standard and Regulations, Mathematical Aptitude, GDT, Technical Aptitude
• General Competencies : Leadership, Teamwork and Collaboration, Analytical Thinking/Problem Solving, Vendor Management, Multitasking, Self-Motivated, Verbal and Written Communication

Benefits

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives : www.abbottbenefits.com

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. www.abbott.com

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