Senior Design Assurance Engineer

Abbott; Plymouth (MN); On-site; USD 75,000 - 151,000; Full time

Job summary

Join a forward-thinking company as a Senior Design Assurance Engineer in the Electrophysiology division, where you will play a crucial role in advancing heart disease treatments. This position offers the chance to work on cutting-edge medical technologies, ensuring compliance with rigorous standards while collaborating with diverse engineering teams. You will lead verification and validation efforts, manage risk assessments, and mentor new engineers, all while enjoying a supportive work environment that values your contributions. With competitive pay and comprehensive benefits, this role is a unique opportunity to make a real impact in healthcare.

Benefits

Free Medical Coverage

Excellent Retirement Savings Plan

Tuition Reimbursement

Career Development Opportunities

Diversity and Inclusion Initiatives

Qualifications

• 5+ years of experience in engineering with strong technical writing skills.
• Knowledge of FDA regulations and quality methodologies is preferred.

Responsibilities

• Lead design verification and validation activities for medical devices.
• Collaborate with cross-functional teams to ensure product quality and safety.

Skills

Technical Writing

Root Cause Identification

Problem Solving

Communication Skills

Education

Bachelor's Degree in Engineering or Science

Degree in Material Science, Mechanical, Biomedical, Electrical, or Chemical Engineering

Tools

Quality Tools/Methodologies

FDA Regulations

ISO 13485

ISO 14971

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 114,000 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.
• 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 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 our Plymouth, MN location in the Electrophysiology division. 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 the Senior Design Assurance Engineer, you will represent Design Assurance on electrophysiology catheter and disposable sustaining engineering projects. This role is responsible for maintaining a strong collaborative partnership with cross-functional engineering teams to ensure that devices are developed and maintained in accordance with product requirements, and that they meet their intended use delivering the safest experience possible to our patients. This role will review requirements, specifications, and technical design documents to provide timely feedback aimed at improving product quality, safety, reliability, and manufacturability to sustaining engineering teams.

What You’ll Work On

• 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
• Maintain DHF, design input / design output, external requirements, and risk management documentation.
• Lead risk management meetings assessing the impact of product or supplier changes to risk profile.
• Lead and execute design verification and validation activities including test planning and execution, and creation of protocols and reports.
• Interpret external standards and implement product requirements and testing to meet external standards.
• Ensure DHF content completion, integrity, and regulatory and standards compliance; collaboratively communicating and resolving gaps.
• Lead, design, test, and inspection method development validation activities.
• Lead root cause investigations, including corrective and preventive action activities, with the purpose of identifying the underlying issues and offering efficient long-term solutions.
• Present to the director level on significant matters.
• Serve as a front-room representative during internal and external inspections and inquiries from regulators such as FDA and ISO as it relates to design assurance.
• Ability to work both within a team, and independently, in a geographically diverse business environment.
• Serves as a resource in the selection, orientation, and training of new engineers and employees.
• Mentor employees by sharing technical expertise and providing feedback and guidance.
• Strong verbal and written communications with effective communication at multiple levels in the organization.
• Perform other duties and responsibilities as assigned by functional management based on the current project/business objectives including 10% travel, including international travel and regular predictable attendance.

Required Qualifications

• Bachelor level degree in an Engineering or Science.
• 5+ years’ experience.
• Strong technical writing skills.
• Experience with root cause identification and problem solving.

Preferred Qualifications

• Degree in Material Science, Mechanical, Biomedical, Electrical, or Chemical Engineering.
• Engineering experience and demonstrated use of Quality tools/methodologies.
• Knowledge of FDA, GMP, ISO 13485, and ISO 14971.
• Prior medical device experience.

Apply Now

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.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. Abbott is an Equal Opportunity Employer, committed to employee diversity.

The base pay for this position is $75,300.00 – $150,700.00.

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

JOB FAMILY:

Operations Quality

DIVISION:

EP Electrophysiology

LOCATION:

United States > Minnesota > Plymouth : 5050 Nathan Lane N

WORK SHIFT:

Standard

TRAVEL:

No

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).