Engineering Supervisor Process Engineering

Mainerafting; Scarborough (ME); On-site; USD 87,000 - 173,000; Full time

Benefits offered by this job

Health benefits

Retirement plan

Tuition reimbursement

Education benefit

Strong employer recognition

Job summary

Abbott Rapid Diagnostics in Scarborough, Maine, seeks an Engineering Supervisor Process Engineering to lead a team of engineers and technicians supporting diagnostic product manufacturing. You will drive capital planning, process improvements, and equipment qualification to ensure compliant, state-of-the-art processes.

The role requires FDA/ISO knowledge, Lean/Six Sigma experience, and strong leadership within a regulated environment. Join Abbott to advance health and patient outcomes worldwide.

Qualifications

• 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).

Responsibilities

• Lead and develop a team of process engineers and technicians to support daily manufacturing operations.
• Set priorities, monitor performance, and align with production goals and quality standards.
• Coach, mentor, and develop the team’s skills and capabilities.
• Oversee design, control, and improvement of manufacturing processes for diagnostic product production.
• Ensure processes are robust, repeatable, and compliant with regulatory requirements.
• Collaborate with Quality and Operations to maintain compliance and efficiency.
• Drive process validation and equipment qualification activities including IQ/OQ/PQ.
• Maintain documentation and data integrity in SOPs and engineering records.

Skills

Leadership

Team Development

Problem Solving

Data Analysis

Communication

Education

Bachelor's degree in Engineering

Tools

IQ/OQ/PQ

Equipment qualification

DOE methods

Job description

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 115,000 colleagues serve people in more than 160 countries.

Engineering Supervisor Process Engineering

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You’ll also have access to:

• Career development with an international company where you can grow the career you dream of.

• Employees can qualify forfree medical coverage in ourHealth Investment Plan (HIP) PPOmedical 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.

The 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 position of Engineering Supervisor Process Engineering is within our Infectious Disease Business Unit locatedin 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.

What You’ll Work On

• The Process Engineering Supervisor is responsible for leading and developing a team of process engineers and technicians to support daily manufacturing operations.
• This includes setting priorities, monitoring performance, and ensuring alignment with production goals and quality standards.
• The role emphasizes coaching, mentorship, and continuous skill development.
• This position oversees the design, control, and improvement of manufacturing processes used in diagnostic product production.
• The supervisor ensures processes are robust, repeatable, and capable of meeting product specifications and regulatory requirements.
• Close collaboration with Quality and Operations is essential to maintain compliance and efficiency.
• The supervisor drives process validation and equipment qualification activities, including IQ/OQ/PQ protocols.
• This role ensures that all validation documentation is completed accurately and meets FDA and ISO requirements.
• Continuous monitoring of validated processes is required to sustain state of control. Troubleshooting manufacturing issues, leading root cause investigations, and implementing corrective and preventive actions (CAPA).
• The supervisor applies structured problem-solving methodologies to resolve yield, quality, and equipment-related challenges. Timely resolution of issues is critical to minimize production disruptions.
• Continuous improvement is a core responsibility, with a focus on Lean manufacturing and Six Sigma principles. The supervisor identifies opportunities to improve efficiency, reduce waste, and enhance product quality. They lead and track improvement initiatives to deliver measurable business impact.
• The role requires collaboration with cross-functional teams, including Production, Quality, Supplier Quality, and Supply Chain.
• The supervisor ensures technical alignment and effective communication across departments. They also provide technical expertise during audits and inspections as required.
• The supervisor is responsible for maintaining accurate documentation, including standard operating procedures (SOPs), work instructions, and engineering records. They ensure compliance with document control systems and data integrity requirements

COMPETENCIES:

• Leadership & Team Development – Ability to lead, coach, and develop high-performing engineering teams in a regulated manufacturing environment
• Technical Expertise – Strong understanding of diagnostics manufacturing processes, including assay/reagent production and automated systems
• Problem Solving & Root Cause Analysis – Proficiency in structured methodologies (e.g., DMAIC, 5 Whys, Fishbone) to resolve complex manufacturing issues
• Quality Compliance – Deep knowledge of FDA, ISO 13485, GMP, and data integrity requirements with strong quality mindset
• Process Improvement Mindset – Demonstrated ability to drive improvement initiatives to improve yield, efficiency, and cost
• Cross-Functional Collaboration – Effective at working across multiple departments
• Data-Driven Decision Making – Skilled in analyzing process data, statistical tools, and KPIs to guide improvements and ensure process control
• Communication Skills – Clear and effective communicator with the ability to translate technical concepts to diverse audiences and stakeholders
• Process Validation Expertise – Deep experience in IQ/OQ/TMV/PQ/, process characterization, and maintaining validated state in compliance with quality requirements

Required Qualifications

• 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

PREFERRED QUALIFICATIONS:

• 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

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. Abbott is an Equal Opportunity Employer, committed to employee diversity.

Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott, and on Twitter @AbbottNews.

The base pay for this position is $86,700.00 – $173,300.00. In specific locations, the pay range may vary from the range posted.