Senior Design Assurance Engineer
Minneapolis, MN 55441 In-Person
1 month ago
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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:
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
Required Qualifications
Preferred Qualifications
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.
Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.
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
ADDITIONAL LOCATIONS:
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)
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
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.
Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.
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
ADDITIONAL LOCATIONS:
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)
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
About Abbott
Learn More About AbbottAbbott 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.
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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.
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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.
