Principal Manufacturing Molding EngineerThe Opportunity Abbott Rapid Diagnostics is part of Abbott's Diagnostics family of businesses, bringing together exceptional teams of experts and industry leading technologies to support diagnostic testing which provides important information for treatment and management of diseases and other conditions.
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.
- 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.
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: Subject matter expert in injection molding process and mold tooling design and construction for medical devices.
- Tooling Design: Mastery in tooling design concepts and key pitfalls, mold development process; mold build, maintenance and refurbishment
- Part Design: Mastery in creating detailed specifications and models for individual components within a larger system, ensuring seamless integration.
- Qualification or Validation: Mastery in the systematic process of ensuring that a product, system, or component meets the specified requirements and performs as intended
- CAD: Proficient in computer-aided design (CAD) and manufacturing software for designing system layouts.
- Industry Standard and Regulations: Mastery in all relevant industry standards and regulations.
- Mathematical Aptitude: Mastery in working with mathematical concepts such as ANSI/AQL, probability, and statistics.
- GDT: Proficient in GDT (Geometric Dimensioning and Tolerancing), quality measurement technique and use of SolidWorks.
- Technical Aptitude: Mastery in the ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
- GDT: Experience with GDT (Geometric Dimensioning and Tolerancing), quality measurement techniques and use of SolidWorks.
General Competencies:- Leadership, Teamwork and Collaboration: Demonstrates professional cooperation by working together harmoniously with others, being an integral part of a team, respecting others' contributions, and aligning personal goals with those of the team.
- Analytical Thinking/Problem Solving: The ability to dissect a situation, issue, or problem into smaller components or trace its implications methodically. This involves committing actions based on logical assumptions and information, considering resources, constraints, organizational values, and changing environments.
- Vendor Management: Overseeing and coordinating relationships with suppliers and service providers to ensure that an organization receives high-quality goods and services.
- Multitasking: Demonstrates the ability to handle multiple tasks or responsibilities simultaneously by efficiently managing time, prioritizing tasks, and maintaining productivity across different activities.
- Self-Motivated: Demonstrates a proactive attitude, consistently drives personal and team goals, and maintains high productivity with minimal external supervision.
- Verbal and Written Communication: Effectively conveys ideas in both individual and group settings, adapting style and methods to suit the audience's needs, both verbally and in writing.
Apply NowLearn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com
The base pay for this position is $99,300.00 - $198,700.00
In specific locations, the pay range may vary from the range posted.
JOB FAMILY:Engineering
DIVISION:ID Infectious Disease
LOCATION:United States > Scarborough : 10 Southgate Rd
ADDITIONAL LOCATIONS:WORK SHIFT:Standard
TRAVEL:Yes, 25 % of the Time
MEDICAL SURVEILLANCE:Not Applicable
SIGNIFICANT WORK ACTIVITIES:Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday), Wear ear plugs, Work in a clean room environment, Work in noisy environment
