Engineering Supervisor Process Engineering

Abbott • Westbrook, ME

1d • Onsite

About The Position

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 position of Engineering Supervisor Process Engineering is within our 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.
• Setting priorities, monitoring performance, and ensuring alignment with production goals and quality standards.
• Coaching, mentorship, and continuous skill development.
• 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.
• Close collaboration with Quality and Operations to maintain compliance and efficiency.
• Driving process validation and equipment qualification activities, including IQ/OQ/PQ protocols.
• Ensuring all validation documentation is completed accurately and meets FDA and ISO requirements.
• Continuous monitoring of validated processes to sustain state of control.
• Troubleshooting manufacturing issues, leading root cause investigations, and implementing corrective and preventive actions (CAPA).
• Applying structured problem-solving methodologies to resolve yield, quality, and equipment-related challenges.
• Timely resolution of issues to minimize production disruptions.
• Continuous improvement, with a focus on Lean manufacturing and Six Sigma principles.
• Identifying opportunities to improve efficiency, reduce waste, and enhance product quality.
• Leading and tracking improvement initiatives to deliver measurable business impact.
• Collaboration with cross-functional teams, including Production, Quality, Supplier Quality, and Supply Chain.
• Ensuring technical alignment and effective communication across departments.
• Providing technical expertise during audits and inspections as required.
• Maintaining accurate documentation, including standard operating procedures (SOPs), work instructions, and engineering records.
• 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 - an affordable and convenient path to getting a bachelor’s degree.

What This Job Offers

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