Abbott

Makes heart devices, glucose sensors and lab tests

Advanced Process Engineer - Automation & Manufacturing Systems

Manufacturing EngineeringConfirmed live in the last 24 hours

Full-timeAlameda, CA, USA$114k - $228k

About the Job

Requirements

A bachelor's degree in Engineering or a related technical discipline is required.
At least 10 years of experience in process engineering, manufacturing engineering, or automation within a regulated industry is required.
Hands-on experience with automated equipment design, integration, commissioning, and validation is required.
Demonstrated success implementing automation solutions that improve efficiency, throughput, and product quality is required.
Strong experience with process validation methodologies, including installation qualification, operational qualification, and performance qualification, is required.
Proficiency in statistical analysis and process optimization techniques is required.
Experience with programming or scripting tools such as Python, SQL, or similar technologies for process automation, data analysis, and reporting is required.

Responsibilities

Lead the design, development, and implementation of automated manufacturing systems, including robotics, machine vision, and integrated production equipment.
Develop user requirement specifications, equipment specifications, and acceptance criteria.
Manage vendor selection, equipment development, factory acceptance testing, site acceptance testing, installation, and commissioning activities.
Improve equipment performance, reliability, uptime, and overall manufacturing efficiency using data-driven methodologies.
Lead process development and scale-up activities from research and development through commercial production.
Design robust, repeatable manufacturing processes focused on automation and scalability.
Develop and maintain manufacturing documentation, including standard operating procedures, work instructions, process failure mode and effects analyses, control plans, validation protocols, and design of experiments reports.
Establish validated process parameters and operating ranges using statistical analysis.
Evaluate manufacturing line layouts, capacity, and cycle times to optimize throughput and efficiency.
Lead continuous improvement initiatives focused on yield enhancement, process capability, and cost reduction.
Lead installation qualification, operational qualification, performance qualification, and test method validation activities for equipment and manufacturing processes.
Ensure compliance with ISO 13485, 21 CFR Part 820, and other applicable regulatory standards.
Conduct risk assessments using process failure mode and effects analysis and support ISO 14971 risk management activities.
Manage change control activities for equipment, processes, and validated systems.
Develop and execute project plans, timelines, and technical deliverables for automation and process engineering programs.
Monitor project milestones, identify risks, and communicate progress to stakeholders.
Collaborate with cross-functional teams and external manufacturing partners to achieve project objectives.
Monitor key manufacturing metrics, including first-pass yield, cycle time, equipment uptime, and defect rates.
Implement process monitoring and data collection strategies to support operational excellence.
Troubleshoot process and equipment issues using structured problem-solving methodologies.
Support ongoing manufacturing operations through process optimization and technical leadership.

Desired Qualifications

Experience supporting medical device manufacturing environments is preferred.
Knowledge of Lean Manufacturing and Six Sigma methodologies is preferred.
Experience working with third-party manufacturing partners and technology transfers is preferred.
Experience integrating manufacturing systems and workflows, including manufacturing execution systems, quality management systems, enterprise resource planning platforms, application programming interfaces, and database connectivity is preferred.

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.

JOB DESCRIPTION:

The Advanced Process Engineer – Automation & Manufacturing Systems is the technical lead for manufacturing process development and automation within Third-Party Manufacturer (TPM) Operations. This role is responsible for developing, integrating, validating, and sustaining automated manufacturing equipment and processes as products transition from R&D into commercial production.

The ideal candidate brings deep expertise in automation, manufacturing systems, process validation, and continuous improvement. This individual will partner across Engineering, Operations, Quality, Supply Chain, and external manufacturing partners to deliver scalable, compliant, and efficient manufacturing solutions.

Key Responsibilities

Automation & Equipment Engineering

Lead the design, development, and implementation of automated manufacturing systems, including robotics, machine vision, and integrated production equipment.
Develop User Requirement Specifications (URS), equipment specifications, and acceptance criteria.
Manage vendor selection, equipment development, Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), installation, and commissioning activities.
Drive improvements in equipment performance, reliability, uptime, and overall manufacturing efficiency using data-driven methodologies.

Process Development & Manufacturing Transfer

Lead process development and scale-up activities from R&D through commercial production.
Design robust, repeatable manufacturing processes with a focus on automation and scalability.
Develop and maintain manufacturing documentation, including SOPs, work instructions, PFMEAs, control plans, validation protocols, and DOE reports.
Establish validated process parameters and operating ranges using statistical analysis.
Evaluate manufacturing line layouts, capacity, and cycle times to optimize throughput and efficiency.
Drive continuous improvement initiatives focused on yield enhancement, process capability, and cost reduction.

Validation & Regulatory Compliance

Lead IQ, OQ, PQ, and TMV activities for equipment and manufacturing processes.
Ensure compliance with ISO 13485, 21 CFR Part 820, and other applicable regulatory standards.
Conduct risk assessments using PFMEA and support ISO 14971 risk management activities.
Manage change control activities for equipment, processes, and validated systems.

Project Leadership

Develop and execute project plans, timelines, and technical deliverables for automation and process engineering programs.
Monitor project milestones, identify risks, and communicate progress to stakeholders.
Collaborate with cross-functional teams and external manufacturing partners to achieve project objectives.

Manufacturing Performance & Continuous Improvement

Monitor key manufacturing metrics, including first-pass yield, cycle time, equipment uptime, and defect rates.
Implement process monitoring and data collection strategies to support operational excellence.
Troubleshoot process and equipment issues using structured problem-solving methodologies.
Support ongoing manufacturing operations through process optimization and technical leadership.

Qualifications

Required

Bachelor's degree in Engineering or a related technical discipline.
10+ years of experience in process engineering, manufacturing engineering, or automation within a regulated industry.
Hands-on experience with automated equipment design, integration, commissioning, and validation.
Demonstrated success implementing automation solutions that improve efficiency, throughput, and product quality.
Strong experience with process validation methodologies, including IQ/OQ/PQ.
Proficiency in statistical analysis and process optimization techniques.
Experience with programming or scripting tools such as Python, SQL, or similar technologies for process automation, data analysis, and reporting.

Preferred

Experience supporting medical device manufacturing environments.
Knowledge of Lean Manufacturing and Six Sigma methodologies.
Experience working with third-party manufacturing partners and technology transfers.
Experience integrating manufacturing systems and workflows, including MES, QMS, ERP platforms, APIs, and database connectivity.

Core Competencies

Automation Expertise: Strong knowledge of automation systems, robotics, vision systems, and manufacturing equipment integration.
Technical Leadership: Ability to lead complex engineering initiatives and drive successful execution.
Quality & Compliance: Understanding of regulatory requirements, validation, and risk management principles.
Data-Driven Problem Solving: Ability to leverage analytics and statistical methods to optimize manufacturing performance.
Cross-Functional Collaboration: Effective communicator and partner across technical and operational teams.
Continuous Improvement Mindset: Focused on operational excellence, scalability, and sustainable process improvement.

The base pay for this position is

$114,000.00 – $228,000.00

In specific locations, the pay range may vary from the range posted.

JOB FAMILY:

Engineering

DIVISION:

ADC Diabetes Care

LOCATION:

United States > Alameda : 2801 Harbor Bay Parkway

ADDITIONAL LOCATIONS:

WORK SHIFT:

Standard

TRAVEL:

Yes, 10 % of the Time

MEDICAL SURVEILLANCE:

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), Continuous walking for prolonged periods (more than 2 hours at a time in an 8 hour day)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.pdfEEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf

About the Company

Abbott

Makes heart devices, glucose sensors and lab tests

Abbott makes medical devices, diagnostic tests, nutrition products and branded generic drugs for hospitals, laboratories, pharmacies and patients. Its best-known product is the FreeStyle Libre, a coin-sized sensor worn on the upper arm that tracks blood sugar around the clock without routine finger pricks. Its other lines run from heart valves, pacemakers and brain stimulators to lab analyzers, rapid tests and mail-in colon cancer screening kits, and Abbott earns money by selling these products to health systems, labs, retailers and consumers. The company was founded in 1888 by Chicago physician Wallace Abbott and is based in Abbott Park, Illinois.

Company size: 10,001+
Company stage: IPO
Headquarters: Abbott Park, IL
Founded: 1888

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