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Engineering Manager

4 months ago


Princeton, United States Abbott Laboratories Full time

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 114,000 colleagues serve people in more than 160 countries.

** PLEASE NOTE: This is not an active open requisition. We are building a candidate slate for a future openings**

 

About Abbott

Abbott is a global healthcare leader, creating breakthrough science to improve peopleâs health. Weâre 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. Youâll also have access to:

Career development with an international company where you can grow the career you dream of.

  • 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 bachelorâs 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.

 

Abbott Point of Care is a global leader in providing critical medical diagnostic and data management products for rapid blood analysis that are intuitive, reliable, and cost-effective.  Our i-STAT System is an advanced, portable diagnostic tool that provides real-time, lab-quality results within minutes to accelerate patient-care decision-making. The i-STAT System has the industryâs most comprehensive menu of tests in a single, with-patient platform, including tests for blood gases, electrolytes, chemistries, coagulation, hematology, glucose, and cardiac markers. By delivering lab-quality results in minutes, our i-STAT System fosters a collaborative, patient-centered environment while driving improved operational performance.

 

The Opportunity

 

Our Princeton, NJ location has an opportunity for an Engineering Manager responsible for leading the Instrument Operations technical group within APOC that is responsible for i-STAT 1 hardware system on market support. relocation assistance provided for right candidate.

In this role, the Engineering Manager will ensure that processes and staffing are appropriately developed and implemented, set strategic vision/goals in alignment with organization, drive utilization of engineering tools including root cause analysis, design for manufacturability, and LEAN to improve manufacturing processes, yields, and equipment during the manufacturing stages of the product and ensure executional compliance within the organization to all applicable internal requirements and external regulations.
 

What youâll do 

  • Manage and resolve manufacturing process, equipment, material, and supplier technical issues to maintain production line up time.

  • Laisse with Third Party Manufactures in Asia on a weekly basis.  This typically involves 2-3 evening conference calls per week.

  • Analyze data and make decisions regarding manufacturing processes, product performance, and quality related events.

  • Provide technical input to Supply Chain when a supplier must be selected or changed or when a last time inventory buy is needed.

  • Manage the identification and qualification of end-of-life BOM components to ensure availability of raw materials.

  • Utilize knowledge and skill to lead organization through resolution of technical challenges, process/equipment improvements, and continuous improvement.

  • Provide technical guidance when requested to resolve component incoming inspection failure resolution by assessing inputs from Quality, Supply Chain, and the supplier.

  • Ensure professional project management techniques are utilized to identify and shorten the critical path tasks in Design Change Package (DCP)/project delivery schedules.

  • Ensures that the engineering group plans and executes on market product DCPs and on market product support engineering tasks to timeline and budget.

  • Coordinates across functional areas and or business units to achieve company and/or area goals.

  • Manage change planning integration with the Manufacturing Software Engineering department to ensure smooth software deployment to manufacturing lines.

  • Make decisions regarding work processes or operational plans and schedules to achieve department objectives.

  • Provide cross-functional communications regarding the status of department and manufacturing performance.

  • Liaise with suppliers to ensure the success of critical projects.

  • Review and approve documents including standard operating procedures, technical specifications, and protocols/reports.

  • Champion a culture of teamwork, communication, and recognition.

  • Recruit, manage, coach, and develop engineering and technical talent.

  • Develop, monitor, and adjust the annual budget for the engineering department.

  • Ensure that continuous improvement is a strong focus for staff via continuous capacity improvement, lower non-conformance rates, and elimination of both time and material waste.

  • Ensure widespread adoption of best practice manufacturing engineering practices such as design for manufacturability, PFMEA, and business excellence.

  • Improve supplier process capability for custom BOM components to ensure continuity of supply.

  • Establish department goals, tracking, and reporting KPIs, and drive continuous improvement efforts.

  • Ensures organizational compliance with company policies/procedures and regulations.

  • Serve on Design Change Control Board to categorize change package requests and authorize advancement.

  • Interface with external agencies during site audits.

  • Negotiate complex quality issue resolution with Quality System leadership and sets strategy approach for the departmentâs quality system nonconformance records.

  • Ensure that all personal and team member training is up to date and in compliance.

  • Support a culture that embraces the safety of the work environment and the safety of our customerâs patients by compliance with company EHS procedures, policies, and GMP requirements.

  • Derive, defend, and adhere to the annual budget for overhead headcount and expenses, project expenses, and capital required to maintain manufacturing operations and implement the necessary cost improvement, supply continuity, product lifecycle management, and regulatory driven changes needed to support the business.

Required Qualifications 

  • Bachelorâs degree in engineering (Mechanical, Electrical, Biomedical, Biochemistry or other applicable STEM fields)

  • 9+ years of relevant work experience or equivalent.

  • 5+ years managing technical team(direct or dotted line   

  • 5+ yearsâ experience in the medical device industry or with a tangential industry that is regulated similarly to ISO13485.  

  • 2+ yearsâ experience in design control and product documentation (Bills of Material, Work Instructions, Drawings, Incoming Inspection) systems.  

  • 1+ year working with Project Management concepts and tools â

  • Experience in appropriate business disciplines (such as quality, operations, engineering) with organizations engaged in the manufacture of FDA regulated products.

  • Strong analytical/technical knowledge and skills to lead organization through collation and analysis of manufacturing data and creation of strategic and tactical plans to achieve goals, drive continuous improvement, and address system, equipment, and process issues.

  • Effective communication skills and experience influencing cross functional organizations such as R&D, Operations, Quality, and other disciplines to achieve project, business, and/or company goals.

  • Ability/experience to execute and mentor others on the utilization of technical tools such as root cause analysis, LEAN, and six sigma.

 

Preferred Qualifications 

  • Strong organizational skills to lead team/department to achieve diverse set of goals and quality system output requirements.

  • Management experience with technical resources and proficiency in the development of employees with diverse backgrounds and experience.

  • Experience with the manufacture or design of electro/mechanical products.

  • Excellent presentation skills.

  • Operational experience in a medical device manufacturing environment.

  • Knowledge of MRP (Manufacturing Resource Planning) system.

  • Familiar with a variety of the production concepts, practices, and procedures.

  • Outstanding interpersonal, verbal, and written communication, problem solving, and time management skills.

  • Demonstrated aptitude for engineering principles and manufacturing systems.

  • MS Office (Excel, PowerPoint, and Word) skills.

WHAT WE OFFER  

 

At Abbott, you can have a good job that can grow into a great career. We offer: 

  • Training and career development, with onboarding programs for new employees and tuition assistance  

  • Financial security through competitive compensation, incentives and retirement plans  

  • Health care and well-being programs including medical, dental, vision, wellness and occupational health programs 

  • Paid time off  

  • 401(k) retirement savings with a generous company match 

  • The stability of a company with a record of strong financial performance and history of being actively involved in local communities 

Learn more about our benefits that add real value to your life to help you live fully:⯠www.abbottbenefits.com  

Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. 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 @Abbott News and @AbbottGlobal. 



The base pay for this position is $109,300.00 â $218,700.00. In specific locations, the pay range may vary from the range posted.