The position of Senior Manufacturing Process Engineer is within our Infectious Disease Business Unit located in Scarborough, Maine. This role is responsible for leading manufacturing equipment initiatives and driving quality, productivity, and cost improvement projects across the operation. The Senior Manufacturing Process Engineer will identify and implement process and material improvements to enhance manufacturing efficiency, reduce production costs, support equipment optimization, and contribute to new product development and commercialization efforts.
What You’ll Work On
Own and maintain manufacturing processes, ensuring alignment with product specifications, process capabilities, and test method requirements.
Lead process and equipment improvement initiatives to enhance quality, efficiency, throughput, and cost performance.
Evaluate and implement manufacturing and design alternatives using Design for Manufacturability (DFM) principles.
Solve complex technical challenges using structured problem-solving methodologies, statistical tools, and data-driven decision making.
Design and execute engineering studies, including DOE methodologies, to support process optimization and validation activities.
Lead equipment implementation, startup, qualification, and process validation activities, including IQ/OQ/PQ protocol development and execution.
Ensure compliance with Design Controls, Process Validation requirements, FDA regulations, ISO standards, cGMP requirements, and internal Quality Management System (QMS) processes.
Support Quality Incidents, CAPA investigations, root cause analysis, and implementation of corrective and preventive actions.
Analyze raw material specifications and lead evaluations, testing, and validation activities associated with material changes.
Develop, revise, and maintain manufacturing documentation, including SOPs, work instructions, specifications, validation protocols, risk assessments, and engineering procedures.
Conduct audits and assessments to ensure compliance with regulatory, quality, and operational standards.
Lead technical reviews for manufacturing equipment, process changes, product design, and engineering requirements.
Research and implement new manufacturing technologies and engineering solutions to improve operational performance.
Drive change management activities through Agile PLM/PDM systems and established engineering change processes.
Collaborate effectively with cross-functional teams, including Manufacturing, Quality, R&D, Supply Chain, Maintenance, and Regulatory Affairs.
Mentor and provide technical guidance to engineers and technicians to support continuous improvement, compliance, and operational excellence.
Ensure compliance with all applicable FDA, ISO, environmental, safety, and company policies, including OSHA requirements.
Support continuous improvement initiatives and organizational objectives in support of quality, operational, and business goals.
Required Qualifications
Responsible for exhibiting professional behavior with internal and external business partners that reflects positively on the company and is consistent with company policies and practices.
Understand and maintain awareness of the quality and compliance implications associated with the performance of assigned responsibilities.
Support departmental objectives and perform other related duties as assigned.
Bachelor's degree in Engineering or an equivalent combination of education and experience.
7+ years of engineering experience in a manufacturing environment.
Technical expertise in Mechanical, Biomedical, Industrial, Chemical, or a related engineering discipline.
Experience performing engineering calculations, designed experiments, controlled testing, and statistical analysis.
Proficiency with Microsoft Office applications, including Excel, PowerPoint, and Power BI.
Experience with change management principles and practices.
Preferred Qualifications
Experience working in a regulated manufacturing environment operating under FDA, ISO, or comparable quality systems.
Working knowledge of cGMP requirements and ISO 13485 standards.
Proficiency with statistical analysis software such as Minitab or JMP.
Competencies
General Competencies
Multitasking: Effectively manages multiple priorities simultaneously by balancing workload, organizing competing demands, and maintaining productivity in a fast-paced environment.
Verbal and Written Communication: Communicates complex technical information clearly and effectively to diverse audiences through both verbal and written channels.
Analytical Thinking & Problem Solving: Identifies root causes, evaluates alternatives, and develops practical solutions to complex technical and operational challenges.
Strategic Planning: Develops and executes short- and long-term plans that align with business objectives, drive operational improvements, and support cross-functional collaboration.
Vendor Management: Builds and manages relationships with suppliers and service providers to ensure quality, reliability, cost-effectiveness, and continuous improvement.
Technical Competencies
Technical Aptitude: Demonstrates the ability to interpret technical specifications, engineering drawings, schematics, and complex instructions while managing multiple variables and constraints.
Mathematical Aptitude: Applies statistical methods, probability concepts, ANSI/AQL sampling plans, and engineering calculations to support decision-making and process improvements.
Financial Acumen: Understands manufacturing financial metrics, including Cost of Goods Sold (COGS), capital investments, inventory management, profitability, and cost reduction initiatives.
Data Analytics: Collects, analyzes, and interprets manufacturing and quality data using statistical techniques to drive process improvements and support business decisions.
CAD: Experience using computer-aided design (CAD) and related engineering software to support equipment, tooling, and process design activities.
Quality Management Systems (QMS): Experience working within Quality Management Systems and managing change control processes in regulated environments.
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.
- The base pay for this position is
- $78,000.00 – $156,000.00
- In specific locations, the pay range may vary from the range posted.
JOB FAMILY
Manufacturing
DIVISION
ID Infectious Disease
LOCATION
United States > Scarborough : 10 Southgate Rd
ADDITIONAL LOCATIONS
WORK SHIFT
Standard
TRAVEL
Yes, 10 % of the Time
MEDICAL SURVEILLANCE
Not Applicable
SIGNIFICANT WORK ACTIVITIES
Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous walking for prolonged periods (more than 2 hours at a time 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
Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.
EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf
EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf
