Engineering Supervisor Process Engineering

Abbott • Westbrook, ME

1d • $86,700 - $173,300 • Onsite

About The Position

The position of Engineering Supervisor Process Engineering is within Abbott's Infectious Disease Business Unit located in Scarborough, Maine. This role will provide tactical leadership within the Engineering organization. Help to develop and implement the capital plan aligned with the company's business strategy, equipment upgrades, and process design. Ensures engineering readiness to support production and product transfer activities. May represent engineering during internal and external company business meetings. Works within company Quality Management System.

Requirements

• Bachelor’s degree in Engineering (Mechanical, Biomedical, Chemical, or related field) required.
• 5+ years of experience in manufacturing/process engineering within a regulated industry (medical device, pharma, or biotech).
• Demonstrated knowledge of FDA regulations, ISO 13485, GMP, and quality system requirements.
• Proven leadership or supervisory experience, including managing or mentoring engineers/technicians and driving team performance.
• Experience with process validation (IQ/OQ/TMV/PQ), equipment qualification, material qualifications, and continuous improvement methodologies (Lean, Six Sigma).
• Strong problem-solving, root cause analysis, and data-driven decision-making skills in a manufacturing environment.

Nice To Haves

• Advanced degree preferred.
• Experience with in vitro diagnostics (IVD) technologies such as lateral flow, PCR, immunoassays, or reagent/kit manufacturing.
• Six Sigma certification (Green Belt or higher) or formal Lean manufacturing training with demonstrated project impact.
• Experience with automation, robotics, vision systems, or high-throughput manufacturing equipment used in diagnostics production.
• Familiarity with statistical analysis tools (e.g., Minitab, JMP) and application of DOE (Design of Experiments) for process optimization.
• Knowledge of supply chain integration, including raw material variability and critical component management for assay performance.
• Experience working in a fast-paced, high-mix / low- to medium-volume manufacturing environment with frequent product or process changes.

Responsibilities

• Leading and developing a team of process engineers and technicians to support daily manufacturing operations, including setting priorities, monitoring performance, and ensuring alignment with production goals and quality standards.
• Overseeing the design, control, and improvement of manufacturing processes used in diagnostic product production, ensuring processes are robust, repeatable, and capable of meeting product specifications and regulatory requirements.
• Driving process validation and equipment qualification activities, including IQ/OQ/PQ protocols, and ensuring all validation documentation is completed accurately and meets FDA and ISO requirements.
• Troubleshooting manufacturing issues, leading root cause investigations, and implementing corrective and preventative actions (CAPA), applying structured problem-solving methodologies to resolve yield, quality, and equipment-related challenges.
• Identifying opportunities to improve efficiency, reduce waste, and enhance product quality, and leading and tracking improvement initiatives to deliver measurable business impact.
• Collaborating with cross-functional teams, including Production, Quality, Supplier Quality, and Supply Chain, to ensure technical alignment and effective communication across departments.
• Maintaining accurate documentation, including standard operating procedures (SOPs), work instructions, and engineering records, and ensuring compliance with document control systems and data integrity requirements.

Benefits

• 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.
• Health and wellness benefits.

What This Job Offers

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