Senior Manufacturing Process Engineer
1016 Abt Molecular Inc.
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Benefits offered by this job
Job summary
Abbott Des Plaines site is seeking a Senior Manufacturing Process Engineer to support new and existing equipment and processes in molecular diagnostics manufacturing. The role emphasizes equipment upgrades, process improvements to reduce costs, and quality enhancements, leading cross‑functional teams and ensuring regulatory compliance.
The position requires 4–6 years in mid‑volume manufacturing with experience in medical devices, equipment procurement, and validation.
Qualifications
- B.S. in Engineering or equivalent experience.
- Mechanical, Electrical and Manufacturing experience.
- 4–6 years in mid-volume manufacturing; medical device exp. preferred.
- Experience with equipment specification and procurement; includes process and packaging.
- Experience with MS Project and SAP.
- Strong mechanical and electrical aptitude.
- 10% travel for FAT and related activities.
- Familiarity with equipment qualification and regulatory requirements.
Responsibilities
- Implement and maintain the site Quality System.
- Lead capital projects: equipment design, procurement, installation, qualification, commissioning.
- Support site capital planning and CAPEX requests.
- Collaborate with suppliers to define project requirements, budgets, timelines.
- Coordinate equipment qualification and validation activities.
- Investigate performance, reliability, and yield issues; implement corrective actions.
- Create and manage Quality System documentation for equipment performance and maintenance.
- Build relationships with contractors, suppliers, and external technical resources.
- Direct third‑party resources to ensure equipment and systems perform as intended.
- Collaborate with external consultants and engineering teams across Abbott divisions.
- Develop and revise technical documentation: SOPs, validation protocols, PM procedures.
Skills
Education
Tools
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 122,000 colleagues serve people in more than 160 countries.
Working at Abbott At Abbott, you can do work that matters, grow, 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 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.
- 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.
As a leader in molecular diagnostics, Abbott is committed to providing solution-oriented offerings. Building on a proven track record of service to the worldwide community of researchers and clinicians, Abbott Molecular continues to deliver patented Vysis FISH technology and RealTime PCR assays that enable your laboratory to partner with healthcare providers. The Abbott Des Plaines location develops and manufactures assays for the detection of infectious diseases. Our location in Des Plaines, IL currently has an opportunity for a Senior Manufacturing Process Engineer. As a member of the Engineering Department, the Senior Manufacturing Process Engineer will provide engineering support for new and existing equipment and processes used in Abbott Molecular's manufacturing operations. This role is responsible for developing and implementing equipment upgrades and process improvements that reduce costs, improve product quality, and enhance operational efficiency. The engineer will participate in and lead cross‑functional project teams to deliver engineered solutions for new equipment, products, and manufacturing processes. Additionally, this individual will implement, document, validate, and maintain controlled, repeatable production processes that support regulatory compliance and manufacturing excellence.
- Implement and maintain the effectiveness of the site Quality System.
- Lead capital projects, including the selection, design, procurement, installation, qualification, and commissioning of manufacturing equipment.
- Support site capital planning activities, including long‑range capital planning and preparation of capital expenditure requests.
- Partner with equipment suppliers to define project requirements, deliverables, budgets, and timelines, ensuring successful project execution.
- Coordinate and execute equipment qualification and validation activities to verify performance and regulatory compliance.
- Investigate and resolve equipment performance, reliability, and yield issues, implementing corrective actions to maintain operations within validated parameters.
- Create and manage Quality System documentation to ensure equipment performance and maintenance history are accurately documented.
- Build and maintain effective relationships with contractors, equipment suppliers, service providers, and external technical resources.
- Direct third‑party resources and contractors to ensure equipment and systems perform as intended.
- Collaborate with external consultants, supplier technical teams, and engineering colleagues across Abbott divisions.
- Develop and revise technical documentation, including operating procedures, validation protocols, preventive maintenance procedures, and material specifications.
- Provide technical guidance to manufacturing personnel to support safe, compliant, and efficient operations.
- Perform additional duties and project assignments as required.
- B.S. in any Engineering discipline or equivalent experience.
- Mechanical, Electrical and Manufacturing Experience.
- 4-6 years of experience, preferably in a mid-volume manufacturing environment, including some or all of the following: Medical device manufacturing experience strongly preferred. Progressive experience with equipment specification and procurement, with emphasis on process and packaging manufacturing solutions, small-volume aseptic filling, capping, torquing, label printing, application, and inspection systems.
- Ability to communicate effectively and engage cross-functional teams on all aspects and responsibilities required for equipment installation and qualification.
- Experience with MS Project and SAP.
- PMP certification beneficial but not required.
- Strong mechanical and electrical aptitude.
- 10% travel required for equipment acceptance, Field Acceptance Testing (FAT), and related activities.
- Familiarity with equipment qualification processes and regulatory requirements in the medical device industry, including Design Review, User Requirement Specifications (URS), FAT, SAT, IQ/OQ/PQ, ISO 8, and related standards.
- Experience in two or more of the following: Working knowledge of industrial robotics, HMI, or PLC programming and troubleshooting.
- Hands‑on programming experience in an object‑oriented language; C# and/or VB.NET preferred.
- Experience with industrial machine vision systems for inspection, guidance, and OCR applications.
- Cognex spreadsheet experience preferred; other machine vision experience is also valuable.
- Experience using CAD software such as AutoCAD, SolidWorks, or similar tools, including the mechanical design of simple components and assemblies.
- Experience with data analysis, design of experiments (DOE), and data parsing using tools such as Power BI, Tableau, JMP, or Minitab, or programming languages such as Python or R.
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: Engineering DIVISION: AMD Molecular LOCATION: United States > Des Plaines : DP01
ADDITIONAL LOCATIONS: WORK SHIFT: Standard TRAVEL: Not specified MEDICAL SURVEILLANCE: Not Applicable SIGNIFICANT WORK ACTIVITIES: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous standing for prolonged periods (more than 2 consecutive hours 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
Abbott is about the power of health. For more than 135 years, Abbott has been helping people reach their potential — because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 160 countries, we create new solutions — across the spectrum of health, around the world, for all stages of life. Whether it’s next‑generation diagnostics, life‑changing devices, science‑based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health.
The people of Abbott come to work each day with relentless energy, enthusiasm and a promise to enhance the health and well‑being of millions of people. They push the boundaries to help manage and treat some of life’s greatest health challenges. We invite you to explore opportunities at Abbott, to see if your talents and career aspirations may fit with our openings. An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.
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