Director, Engineering Test Devices
3 days ago
Our Client Abbott, a global healthcare leader that helps people live more fully at all stages of life, is in urgent need of a
Director, Engineering Test Devices
to work onsite at their manufacturing plant located in Scarborough, Maine. Their 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:
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 their Maine location of the Infectious Disease division.
As the Director, Engineering Test Devices, you’ll provide technical leadership to the process development organization and manage process development activities from design refinement through commercialization.
What You’ll Work On
Lead process technology advancement and design for manufacturability activities. Develop high performing, repeatable, low cost manufacturing processes.
Provide work direction to engineers and technicians and set project priorities for the process development team.
Direct process characterization, PFMEA’s, process validation, and defect prevention/process control activities.
Manage the development of manufacturing engineering procedures, processes, and qualifications including IQ, OQ, and PQ protocols and execution.
Responsible for process, equipment, and fixturing design and development.
Ensure manufacturing processes are LEAN, maximize direct labor efficiency, and support continuous flow production.
Responsible for process ergonomics and overall safety.
Assist with supplier selection, supplier qualification, and supplier development activities.
Serve as project manager during the transfer of products from development into production.
Champion employee development and provide technical mentoring to engineers and technicians.
Develop key performance metrics and manage the business with a continuous improvement philosophy.
Develop the manufacturing budget and manage expenses to plan.
Perform job functions in accordance with GMP and ISO standards.
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
Bachelor’s degree in mechanical engineering or a related field.
Minimum 10 years of experience.
Experience in Medical Device with at least 5 years in a medical device management role.
Working knowledge of a formal Product Development Process (PDP) for medical device development activities. Experience with product development activities from product concept through production transfer and ramp.
Demonstrated history of technical accomplishment in the areas of process development, process technology advancement, cost reduction, and process flow improvement.
Overall knowledge of manufacturing, quality assurance, and quality control as well as appropriate regulatory guidelines.
Demonstrated leadership and change management abilities.
Working knowledge of GMP and ISO regulations is required.
Demonstrated ability to hire, develop, and retain highly competent employees.
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.
Ability to travel, including internationally.
Preferred Qualifications
Master’s Degree
Nitinol, braiding, and/or polymer experience
Experience working in a broader enterprise/cross division business unit model
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