Abbott

Senior Engineer Development Quality

Abbott • $78K — $156K *
Minnetonka, MN 55345In-Person
Pharmaceuticals & Biotech
5 - 7 years of experience
Reposted Today
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Job Overview by Ladders

Qualifications

  • Bachelor's degree in science, engineering, or a related field (± 16 years) or equivalent experience.
  • Master's degree preferred (± 18 years).
  • Minimum of 5 years of experience in Quality, Compliance, or Engineering within regulated environments like medical devices or pharmaceuticals.
  • Knowledge of US and international Quality System Requirements, including ISO 13485 and software regulations (21 CFR Part 11).
  • Strong understanding of quality management techniques and statistical analysis.
  • Demonstrated initiative, critical-thinking, and problem-solving skills.

Responsibilities

  • Lead timely completion of Design Control Deliverables.
  • Create and execute Quality Plans for development and design change projects.
  • Ensure accountability for Design Verification and Validation planning and execution.
  • Lead Risk Management activities throughout product development.
  • Develop design test and inspection methods and validate them.
  • Ensure compliance with regulatory standards and maintain Document History File integrity.
  • Support and ensure internal and external audit responses.

Benefits

  • Career development opportunities within a globally recognized company.
  • Free medical coverage eligibility in the following calendar year.
  • Robust retirement savings plan with high employer contributions.
  • Tuition reimbursement and programs for student debt relief and bachelor's degree completion.
  • Recognition as a top employer for diversity and workplace excellence globally.
Full Job Description
JOB DESCRIPTION:

MAIN PURPOSE OF THE ROLE

The Senior Engineer, Development Quality assures new or modified products conform to quality standards and establishes compliance with the quality system. Responsible for maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success by
protecting patient/user safety and meeting business needs.

This position is an ONSITE role based out of Minnetonka. MN.

MAIN RESPONSIBILITIES

  • Lead on-time completion of Design Control Deliverables
  • Create and ensure on-time execution of Quality Plans for internal development, OEM-based, Clinical Product Development
  • (CPDP), and design change projects
  • Accountable for Design Verification and Validation planning & execution, including active cross-functional root-cause analysis investigation & resolution activities
  • Lead Risk Management activities from product Concept through Commercialization
  • Lead design test and inspection method development, and lead method validation activities
  • Ensure DHF content completion, integrity, and regulatory & standards compliance; collaboratively communicating & resolving gaps
  • Support manufacturing process development & qualification for new product commercialization and product changes
  • Support/lead and ensure internal & external audit responses
  • Support/lead and ensure on time product re-certifications
  • Support and ensure the establishment of objective, measurable, discrete, and verifiable customer and product requirements
  • Support and ensure objective component specification definitions, supplied component sampling plan development, and vendor qualifications
  • Accountable for development, execution and analysis of biocompatibility and sterilization qualifications
  • Complete Document Change Request Reviews in a timely and objective manner
  • Develop and lead other team members.
  • Perform other duties and responsibilities as assigned by management.
  • Support/lead 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.
  • 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 al levels of employees, customers, contractors, and vendors.


QUALIFICATIONS

Education

  • Bachelors Degree (± 16 years) preferably in science, engineering or a closely related discipline (OR) an equivalent combination of education and work experience
  • Masters Degree (± 18 years) preferred


Experience/Background

  • Minimum 5 years of relevant experience, such as Quality, Compliance, Engineering, within a regulated environment, such as medical device, diagnostics or pharmaceutical industries, to develop the competence required to meet the skills and responsibilities of the position.
  • Knowledge of applicable US and non-US Quality System Requirements and other relevant regulations for medical devices. Previous experience with regulatory body. Knowledge of software regulations and compliance (21 CFR Part 11); - Knowledge of ISO 13485.
  • Knowledge of quality management techniques and the application and principles of quality engineering. Strong 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. Understanding of statistics.
  • 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 and 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.
  • Ability or aptitude to lead without direct authority.


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.

The base pay for this position is
$78,000.00 - $156,000.00
In specific locations, the pay range may vary from the range posted.

JOB FAMILY:
Operations Quality

DIVISION:
CRM Cardiac Rhythm Management

LOCATION:
United States > Minnesota > Minnetonka : 14900 Minnetonka Industrial Road

ADDITIONAL LOCATIONS:

WORK SHIFT:
Standard

TRAVEL:
Yes, 10 % 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)

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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