Manager Manufacturing Process Engineering

Abbott; Pleasanton (CA); On-site; USD 114,000 - 228,000; Full time

Job summary

Abbott in Pleasanton, CA is seeking a Manufacturing Engineering Manager to lead planning and execution of manufacturing and production engineering projects. You will design and develop manufacturing processes, tooling & fixture design and process development products to meet daily production and new product schedules while improving productivity and quality.

This role requires strong leadership, cross-functional collaboration, and adherence to FDA, GMP, and ISO standards.

Qualifications

• BS in Engineering; advanced degree preferred.
• 10 years manufacturing/process development experience with minimum 5 years of technical staff management and 3 years of cross-functional project management.
• 5 years prior experience in medical device manufacturing preferred.
• Experience with statistical techniques (e.g., DOE, SPC).
• Experience with Lean manufacturing techniques, value stream mapping, and continuous improvement methodologies.
• Solid people management and communication skills.
• Solid knowledge of GMP, ISO regulations.
• Demonstrated success in leading mfg technology transfer projects to global operations.
• Experience working in a broader enterprise/cross division business unit model preferred.
• Ability to travel approximately 10%, including internationally.

Responsibilities

• Provide leadership to engineering staff regarding project prioritization, process validations, and continuous improvement activities.
• Implement and manage resource planning and project management tools.
• Collaborate with Manufacturing Engineering Department managers in selecting and scheduling project engineers for Operations projects.
• Support continuing production, process development and new product introductions.
• Monitor and evaluate project and department progress and results.
• Participate in cross-functional teams.
• Review and approve protocol and written reports.
• Drive continuous improvement of engineering technical capabilities.
• Prepare technical reports, analysis, recommendations and presentations reflecting the status and results of projects in progress on a regular basis.
• Coach, manage and develop technical staff.
• Develop, implement, train and monitor effectiveness of engineering systems and procedures to ensure compliance to FDA, GMP and all other applicable agency regulations.
• Ensure a safe work environment consistent with OSHA requirements and Abbott Policies.
• Prepare departmental budgets and control expenditures to stay within spending limits.
• Support all Divisional initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements
• Hires and retains a diverse, highly qualified staff and provides ongoing performance feedback. Sets goals which align to department plans and manages the execution of goals through coaching and mentoring. Maintains a safe and professional work environment.
• Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.

Skills

Leadership

Project management

Manufacturing engineering

Staff management

Lean manufacturing

DOE/ SPC

GMP/ISO

Cross-functional collaboration

Communication

Education

Bachelor of Science in Engineering

Advanced degree preferred

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.

Manufacturing Engineering Manager

About Abbott

Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology.

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and 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.
• Free medical coverage for employees* via the Health Investment Plan (HIP) PPO
• An excellent retirement savings plan with 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 around the world 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 a best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity

This position works out of our Pleasanton, CA in Abbott’s Heart Failure Division. In Abbott’s Heart Failure (HF) business, we’re developing solutions to diagnose, monitor and manage heart failure, allowing people to restore their health and get on with their lives.

We are seeking a high caliber Manufacturing Engineering Manager who will manage the planning and completion of manufacturing/production engineering projects. This will include the design and development of manufacturing processes, tooling & fixture design and process development products in order to meet daily production and new product development schedules while enhancing productivity and product quality.

Each employee can make a difference at Abbott and has the power, either individually or as a team, to influence the success of the company. We are team-oriented, fast-paced and progressive. We value people with great ideas who partner with others both internally and externally to take action and accomplish goals.

What You’ll Work On

• Provide leadership to engineering staff regarding project prioritization, process validations, and continuous improvement activities.
• Implement and manage resource planning and project management tools.
• Collaborate with Manufacturing Engineering Department managers in selecting and scheduling project engineers for Operations projects.
• Support continuing production, process development and new product introductions..
• Monitor and evaluate project and department progress and results.
• Participate in cross-functional teams.
• Review and approve protocol and written reports.
• Drive continuous improvement of engineering technical capabilities.
• Prepare technical reports, analysis, recommendations and presentations reflecting the status and results of projects in progress on a regular basis.
• Coach, manage and develop technical staff.
• Develop, implement, train and monitor effectiveness of engineering systems and procedures to ensure compliance to FDA, GMP and all other applicable agency regulations.
• Ensure a safe work environment consistent with OSHA requirements and Abbott Policies.
• Prepare departmental budgets and control expenditures to stay within spending limits.
• Support all Divisional initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements
• Hires and retains a diverse, highly qualified staff and provides ongoing performance feedback. Sets goals which align to department plans and manages the execution of goals through coaching and mentoring. Maintains a safe and professional work environment.
• Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
• Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.

Required Qualifications

• BS in Engineering; advanced degree preferred.
• 10 years manufacturing/process development experience, with minimum 5 years of technical staff management experience and 3 years of project management experience involving coordination of cross-functional teams.
• 5 years prior experience in medical device manufacturing preferred.
• Experience with statistical techniques (e.g., DOE, SPC).
• Experience with Lean manufacturing techniques, value stream mapping, and continuous improvement methodologies.
• Solid people management and communication skills.
• Solid knowledge of GMP, ISO regulations.
• Demonstrated success in leading mfg technology transfer project to global operations.
• Experience working in a broader enterprise/cross division business unit model preferred.
• Ability to work in a highly matrixed and geographically diverse business environment.
• Strong leadership skills, including the ability to set goals and provide positive and constructive feedback respectfully to build positive relationships and improve business results.
• Ability to work effectively within a team in a fast-paced changing environment.
• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
• Multi-tasks, prioritizes and meets deadlines in timely manner.
• Strong organizational, planning, and follow-up skills and ability to hold others accountable.
• Ability to travel approximately 10%, including internationally.

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.