Abbott Lead Engineer (Design QA) in Princeton, New Jersey

At Abbott, we're committed to helping you live your best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 94,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve. Please note that candidates need to be eligible to work in the U.S. without Abbott sponsorship.

JOB DESCRIPTION:

The point-of-care (POC) testing industry is changing faster than ever. At Abbott Point of Care, we’ve stayed ahead of the curve. We are a worldwide leader in fundamentally changing healthcare delivery at the point of care with solutions that are intuitive, innovative, reliable, and cost-effective for our customers.

The Lead Quality Engineer will work in the Quality Assurance organization as the primary liaison between QA and R & D at Abbott Point of Care.

Primary Responsibilities include:

  • Serve as primary liaison between QA and R & D and/or Operations on projects/programs requiring design control (for new product development).

  • Provide direction to multi-disciplinary personnel involved in product development to arrive at solutions that support the company business objectives and quality standards.

  • Specifically, be able to work with the project teams to document requirements for products in accordance with FDA and other applicable QSR’s.

  • Provide direction with respect to design verification and validation.

  • Utilize clinical knowledge, understanding of competitor’s products, and extrapolation from limited data to assure fitness for use.

  • Contributes to the design, development and implementation of comprehensive product assurance plans providing feedback and corrective action for engineering, manufacturing, service and field operations and suppliers performance.

  • Interpret data to make driven recommendations leading to resolution of issues.

  • Provide and / or participate in Design Control training.

  • Responsible for review and approval of elements of Design Control including but not limited to: Planning, Device History File(s), Change Control and associated and supporting documentation.

  • May have responsibilities for review and approval of DMF, DMR, MVP, and FMEA.

  • Ensures that quality and compliance to site procedures are communicated and implemented.

As the ideal candidate for our team you will bring the following education, experiences, knowledge, and skills to the position:

  • B.Sc. in science or engineering.

  • 10-15 years of Quality Assurance experience in medical device manufacturing or pharmaceutical industries.

  • Design Control Experience is required.

  • Membership on the American Society of Quality Control (ASQ) or Society of Reliability Engineers is an asset.

  • Extensive knowledge of quality regulations and standards, statistical calculation and measurement and manufacturing processes.

  • Extensive working knowledge of GMP, ISO standards, FDA regulations, and Health Canada

  • Superior analytical and problem solving skills and statistical applications experience.

  • Ability to be creative in achieving objectives while assuring compliance to internal and external requirements.

  • Proven organizational and leadership skills. Ability to work under pressure in a fast paced environment.

  • Excellent oral and written communication skills and ability to interact effectively with all levels in the organization.

Qualifications

Bachelor's degree (preferably in Engineering, science or a closely related discipline is desired) or equivalent technical experience and demonstrated competence required; additional post-graduate education may contribute toward the desired years of experience; Typically requires 6-7 years of significant engineering and / or operational experience to develop the competence to meet the skills and responsibilities of the position; Candidates / incumbents should possess the following:

  • strong technical knowledge and application of concepts, practices and procedures;

  • ability or aptitude to work on problems that are complex in scope where analysis of situations or data involves multiple competing factors;

  • ability to form and develop interpersonal, professional relationships; display socially and professionally appropriate behavior;

  • ability to work independently and in groups; ability to work cross-functionally;

  • demonstrated initiative and problem-solving skills; critical-thinking skills;

  • ability and aptitude to use various types of databases and other computer software;

  • ability to prioritize;

  • strong organizational and project management skills;

  • demonstrated competency with financial systems and in fiscal controls;

  • ability to quickly gain knowledge, understanding or skills and is willing to learn; Engineers trained in one branch of the Engineering field may work in related branches of engineering provided demonstrated transferable skills.

JOB FAMILY:

Operations Quality

DIVISION:

APOC Point of Care

LOCATION:

United States > Princeton : 400 College Road East

ADDITIONAL LOCATIONS:

WORK SHIFT:

Standard

TRAVEL:

No

MEDICAL SURVEILLANCE:

No

SIGNIFICANT WORK ACTIVITIES:

Continuous sitting for prolonged periods (more than 2 consecutive hours 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.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 125 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 150 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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