Abbott
Engineering Supervisor Process Engineering
United States > Scarborough : 10 Southgate Rd
Sponsorship not specified$87k-$173kDetected 1 day ago
StatisticsSupply ChainProcess ImprovementHRISRoboticsControlsGMPFDA RegulatoryPCRMedical DevicesLeadershipCommunicationCollaborationProblem SolvingMentoringLean Manufacturing
About the role
- 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.
- May represent engineering during internal and external company business meetings.
Responsibilities
- 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.
- The Process Engineering Supervisor is responsible for leading and developing a team of process engineers and technicians to support daily manufacturing operations.
- This position oversees the design, control, and improvement of manufacturing processes used in diagnostic product production.
- Close collaboration with Quality and Operations is essential to maintain compliance and efficiency.
- They lead and track improvement initiatives to deliver measurable business impact.
- The supervisor drives process validation and equipment qualification activities, including IQ/OQ/PQ protocols.
- They ensure compliance with document control systems and data integrity requirements
- Team Development - Ability to lead, coach, and develop high-performing engineering teams in a regulated manufacturing environment
- Process Improvement Mindset - Demonstrated ability to drive improvement initiatives to improve yield, efficiency, and cost
Requirements
- Bachelor's degree in Engineering (Mechanical, Biomedical, Chemical, or related field) required.
- 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)
- Continuous monitoring of validated processes is required to sustain state of control.
- They also provide technical expertise during audits and inspections as required.
- 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
- Communication Skills - Clear and effective communicator with the ability to translate technical concepts to diverse audiences and stakeholders
- Technical Expertise - Strong understanding of diagnostics manufacturing processes, including assay/reagent production and automated systems
Nice to have
- 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
- 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
- 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
Skills
- Abbott is a global healthcare leader that helps people live more fully at all stages of life.
- Our 115,000 colleagues serve people in more than 160 countries.
Compensation
- The base pay for this position is
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.
Company info
- Works within company Quality Management System.
Equal opportunity
- http://webstorage.abbott.com/common/External/EEO_English.pdf
- http://webstorage.abbott.com/common/External/EEO_Spanish.pdf
- 10 Southgate Rd
- Not specified
This listing is sourced directly from Abbott's careers page and normalized into a canonical job model.