Design Assurance Engineer II

Abbott; Plymouth (MA); On-site; USD 61,000 - 123,000; Full time

Job summary

Abbott in Plymouth, MN is seeking a Design Assurance Engineer II to join the Electrophysiology team. You’ll ensure safety, efficacy, and regulatory compliance for advanced electrophysiology devices from concept through launch, with focus on ablation and diagnostic catheters.

You’ll lead verification/validation activities, apply statistics, and collaborate across disciplines to deliver compliant product designs while supporting audits and DHF integrity.

Qualifications

• Bachelor level degree in Engineering or Technical Field; advanced degree / Biomedical Engineering / Mechanical Engineering preferred.
• 2-3 years Engineering experience with new product development.
• Strong knowledge on design verification and design validation techniques.
• Working knowledge of applied statistics, sampling strategies, and design of experiments, including statistical software tools such as Minitab.
• Strong organizational and follow‑up skills, as well as attention to detail.
• Ability to collaborate on‑site on a regular basis.
• Ability to travel up to 5-10%, including internationally.
• Knowledge of FDA, GMP, ISO 13485, IEC 60601, ISO 14971
• ASQ certification (CQE, CQA) or similar is a plus.

Responsibilities

• Lead and implement complex development projects, including quality improvement initiatives.
• Sets strategies for cross-functional teams and drives towards compliant and efficient solutions to complex problems.
• Execute on holistic & strategic Design Verification/Validation strategies with emphasis on: technical analysis of requirements, specifications, and control strategy; efficient and cost-effective execution of validation and verification; alignment of design outputs to production and process controls; proper verification techniques including inspection, demonstration, test, etc.
• Lead design characterization activities for development projects
• Influence design and verification decisions through use of applied statistics.
• Support design test and inspection method development, and lead method validation activities.
• Ensure DHF content integrity, completeness, and regulatory / standards compliance; collaboratively communicating & resolving gaps.
• Support and ensure internal & external audit responses and on‑time product re‑certifications.
• Support and ensure the establishment of objective, measurable, discrete, and verifiable customer and product requirements.
• 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

Design verification

Design validation

Statistical analysis

Cross-functional collaboration

On-site collaboration

Education

Bachelor’s degree in Engineering or Technical Field

Biomedical/Mechanical Engineering advanced degree preferred

Tools

Minitab

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.

JOB DESCRIPTION:

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and your 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.
• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• An excellent retirement savings plan with a 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 worldwide 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 the best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity

In Abbott’s Electrophysiology (EP) business, we’re advancing the treatment of heart disease through breakthrough medical technologies in atrial fibrillation, allowing people to restore their health and get on with their lives.

As a Design Assurance Engineer II based in Plymouth, MN, you will play a critical role in ensuring the safety, efficacy, and compliance of cutting‑edge electrophysiology products. You will be providing development support as a part of a multidisciplinary product development team, overseeing projects throughout concept to launch in all phases of Design Controls with focus on ablation and diagnostic catheters. You will be a key contributor to the design, development and testing activities for complex medical devices.

What You’ll Work On

• Lead and implement complex development projects including quality improvement initiatives.
• Sets strategies for cross-functional teams and drives towards compliant and efficient solutions to complex problems.
• Execute on Holistic & Strategic Design Verification/Validation Strategies with emphasis on:
  • Technical analysis of requirements, specifications, and control strategy
  • Efficient and cost-effective execution of validation and verification
  • Alignment of design outputs to production and process controls
  • Proper verification techniques including inspection, demonstration, test, etc.
• Lead design characterization activities for development projects
• Influence design and verification decisions through use of applied statistics.
• Support design test and inspection method development, and lead method validation activities.
• Ensure DHF content integrity, completeness, and regulatory / standards compliance; collaboratively communicating & resolving gaps.
• Support and ensure internal & external audit responses and on‑time product re‑certifications.
• Support and ensure the establishment of objective, measurable, discrete, and verifiable customer and product requirements.
• 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.
• Performs other related duties and responsibilities, on occasion, as assigned.

Required Qualifications

• Bachelor level degree in Engineering or Technical Field; advanced degree / Biomedical Engineering / Mechanical Engineering preferred.
• 2-3 years Engineering experience with new product development
• Strong knowledge on design verification and design validation techniques.
• Working knowledge of applied statistics, sampling strategies, and design of experiments, including statistical software tools such as Minitab.
• Strong organizational and follow‑up skills, as well as attention to detail.
• Ability to collaborate on‑site on a regular basis.
• Ability to travel up to 5-10%, including internationally.
• Knowledge of FDA, GMP, ISO 13485, IEC 60601, ISO 14971
• Prior medical device experience, especially electrophysiology or cardiovascular devices preferred.
• ASQ certification (CQE, CQA) or similar is a plus.

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

$61,300.00 – $122,700.00

In specific locations, the pay range may vary from the range posted.

JOB FAMILY:

Engineering

DIVISION:

EP Electrophysiology

LOCATION:

United States > Minnesota > Plymouth : 5050 Nathan Lane N

WORK SHIFT:

Standard

TRAVEL:

Yes, 5 % of the Time

MEDICAL SURVEILLANCE:

No

SIGNIFICANT WORK ACTIVITIES:

Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday)

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