Abbott

Lead Engineer (Design Quality Assurance)

Abbott • $86K — $173K *
Princeton, NJ 08540In-Person
Pharmaceuticals & Biotech
5 - 7 years of experience
Today
Be an Early Applicant
Job Overview by Ladders

Qualifications

  • B.Sc. in science or engineering.
  • 6-10 years of general work experience.
  • 4-6 years of Quality Assurance experience in medical device manufacturing or pharmaceuticals.
  • Design Control Experience is necessary.

Responsibilities

  • Support on-market quality assurance for design control activities.
  • Guide multi-disciplinary teams in product development and quality standards.
  • Define documentation requirements for verifications and validations per FDA QSRs.
  • Implement design control policies and procedures effectively.
  • Analyze and interpret data to inform decision-making and recommendations.

Benefits

  • Comprehensive health and wellness benefits for you and your family.
  • Opportunities for career development and personal growth within Abbott.
Full Job Description
JOB DESCRIPTION:

Lead Engineer (Design Quality Assurance)

The Opportunity
This position works out of our Princeton, NJ location in the Abbott Point of Care Diagnostics Division. We're empowering smarter medical and economic decision-making to help transform the way people manage their health at all stages of life. Every day, more than 10 million tests are run on Abbott's diagnostics instruments, providing lab results for millions of people.

The Lead Engineer (Design Quality Assurance) will work in the Quality Assurance organization at the Abbott Point of Care Princeton.

What You'll Work On
  • Primary on-market quality assurance support for design control activities.
  • Provide guidance and direction to multi-disciplinary personnel involved in product development and production to arrive at solutions that support the company's business objectives and quality standards.
  • Able to define document requirements for products, process and test methods verifications and validations in accordance with FDA QSR's and specific Design Control projects activities.
  • Understanding of process, design and product/design verification/validation.
  • Able to relate information to specifications, product claims and design.
  • Uses clinical knowledge, understanding of competitor's products, and extrapolation from limited data to assure fitness for use.
  • Responsible for implementation of design control policies and procedures.
  • 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.
  • Liaises with project and program team members on technical and quality matters.
  • Analyzing and interpreting data will be an integral part of the daily responsibilities.
  • Able to utilize data to make driven decisions and recommendations.
  • 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 with site procedures are communicated and implemented.


Required Qualifications
  • B.Sc. in science or engineering.
  • 6-10 years of general work experience
  • 4-6 years of Quality Assurance experience in medical device manufacturing or pharmaceutical industries.
  • Design Control Experience is required.


Preferred Qualifications
  • Knowledge of Process Validation is an asset
  • Membership on the American Society of Quality Control (ASQ) or Society of Reliability Engineers is an asset.
  • Good knowledge of quality regulations and standards, statistical calculation and measurement and manufacturing processes.
  • Strong knowledge of inspection methods in design, fabrication and production of electronic equipment. Demonstrated skill in using test and measuring equipment. Working knowledge of GMP, ISO standards, FDA regulations, and Health Canada.
  • Superior analytical and problem-solving skills and statistical applications experience.
  • Ability to be creativity in achieving objectives while assuring compliance with 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.


Apply Now

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: https://abbottbenefits.com/

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life.

The base pay for this position is
$86,700.00 - $173,300.00
In specific locations, the pay range may vary from the range posted.

JOB FAMILY:
Operations Quality

DIVISION:
APOC Point of Care

LOCATION:
United States > Princeton : 400 College Road East

ADDITIONAL LOCATIONS:

WORK SHIFT:
Standard

TRAVEL:
Yes, 5 % of the Time

MEDICAL SURVEILLANCE:
Not Applicable

SIGNIFICANT WORK ACTIVITIES:
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday), Work requiring repeated bending, stooping, squatting or kneeling

About Abbott

Abbott Careers

Joining Abbott means becoming part of a globally diverse team dedicated to making a lasting impact on human health. As a leader in healthcare innovation, Abbott provides a dynamic workplace where careers flourish through growth, leadership, and diversity training.

Opportunities at Abbott

Explore a world of opportunities with our team. Whether you're seeking job opportunities in engineering, marketing, research, or healthcare, Abbott offers a variety of positions that allow professionals to grow their careers. Our commitment to diversity and innovation is evident in every aspect of our work, fostering an inclusive culture that values each team member's contribution.

Work You'll Do

At Abbott, every role contributes to our mission of helping people live fuller lives through better health. From groundbreaking research in medical devices to advancements in pharmaceuticals, our team is at the forefront of healthcare innovation. By joining Abbott, you are not just accepting a job; you are embarking on a path of professional and personal growth.

Internship Programs

Kickstart your career with an Abbott internship. Our programs provide invaluable industry experience and a chance to develop essential skills in a real-world setting. Interns at Abbott work on projects that matter, gaining the experience and knowledge necessary to succeed in their future careers.

Professional Development

Abbott is dedicated to the continuous professional development of its employees. With access to cutting-edge technology, leadership programs, and diversity training, our team members are equipped to lead and innovate within the healthcare industry. We support your career journey with robust training programs, mentorship, and opportunities for networking and professional growth.

Benefits and Culture

Our employees enjoy comprehensive benefits designed to support their life and well-being. From health insurance to retirement plans, we ensure our team has everything they need to thrive. Abbott's culture is built on a foundation of respect and integrity, united by a shared commitment to improving health outcomes.

Join Our Team

Discover the impact you can make with a career at Abbott. We are hiring individuals who are passionate, curious, and driven to lead. Search open positions that match your skills and interests on our Jobs page. Prepare your resume, sharpen your interview skills, and get ready to join a team that's at the cutting edge of healthcare solutions.

Stay Connected

Keep up to date with career tips, industry insights, and company news—all from the people who work here. Subscribe to our Careers Blog and personalize your subscription to receive job alerts and insider tips tailored to your preferences.

Explore Abbott

With a commitment to improving life through innovation, leadership, and diversity, Abbott is a place where you can fulfill your potential. See what exciting and rewarding opportunities await at Abbott by exploring our career opportunities today.

SEARCH ABBOTT JOBS

Join us in our mission to make the world a healthier place through innovation, leadership, and diversity. Your journey to a fulfilling career at Abbott starts here.
Learn more about Abbott
Size
113,000 employees
Market Cap
$189 billion
Industry
Healthcare
Net Income
$4.4 billion
Founded
1944
5 Year Trend
+15.6%
Revenue
$34.6 billion
NASDAQ
ABT
* Ladders Estimates

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