Abbott

Senior Software Design Assurance Engineer

Abbott$78K — $156K *
Healthcare
5 - 7 years of experience
Job Overview by Ladders

Qualifications

  • Bachelor's degree in engineering or a technical field
  • Minimum of 5 years related work experience in Quality or a related field
  • Knowledge of regulations, standards, and guidance affecting medical and non-medical software development
  • Strong verbal and written communication skills
  • Ability to communicate effectively at multiple organizational levels

Responsibilities

  • Provide technical and quality system guides for establishing software requirements
  • Oversee software verification and validation activities and review related documentation
  • Lead meetings to prioritize and approve action plans for addressing development issues
  • Manage risk evaluations related to software development, including FMEA and mitigation strategies
  • Participate in technical and management reviews to ensure product design compliance
  • Assess need for non-product software validation and prepare related documentation
  • Support product cybersecurity assessments with a cross-functional team

Benefits

  • Health and wellness benefits to support employees and families
  • Opportunity to lead quality system improvement activities
  • Potential for professional growth within cross-functional teams
  • Engagement in technical and management reviews to influence product development
  • Collaborative work environment with a strong focus on quality engineering
Full Job Description
JOB DESCRIPTION:

The Senior Software Design Assurance Engineer is responsible for supporting product development, executing and maintaining software quality engineering methodologies, and providing quality engineering support for software. The Senior Software Design Assurance Engineer position focuses primarily on software quality but also supports other aspects of product development based on experience.

What You'll Work On
  • Provides technical and quality system guides related to establishing software requirements.
  • Provide quality oversight for software verification and validation activities for new products in accordance with design planning procedures. This includes, but is not limited to, reviewing and approving software test case protocols and reports, reviewing software development plans, and reviewing other system and software documentation.
  • Leads meetings to prioritize, review, and/or approve action plans for addressing issues captured in problem resolution systems during development.
  • Leads risk evaluation and associated management activities related to software development, including Risk assessments (e.g., FMEA), product risk analysis, and mitigation of software issues.
  • Participates in technical and management reviews to ensure design plans, product design, and deliverables related to product software are met. Represent the quality engineering function for the review and approval of designated design outputs.
  • Provide quality oversight for non-product software validation by assessing the need for validation and preparing and/or supporting protocols, reports, and other documentation as required.
  • May be involved with supporting product cybersecurity assessments in conjunction with a cross-functional team
  • Complies with US FDA regulations, other country regulatory requirements, company policies, and procedures.
  • Maintains a strong, collaborative partnership with cross-functional team members, especially with R&D.
  • Works as an individual contributor and may provide guidance or oversee the work of other QE team members.
  • Develop and conduct training of company personnel for the divisional software development and validation program.
  • Support audits and lead quality system improvement activities.
  • Additional responsibilities may be assigned as needed.


Required Qualifications:
  • Bachelor's degree in engineering or a technical field
  • Minimum of 5 years related work experience in Quality or a related field.
  • Knowledge of regulations, standards, and guidance affecting medical software and non-medical device software development.
  • Strong verbal and written communication with the ability to effectively communicate at multiple levels in the organization.


Preferred Qualifications:
  • Advanced degree
  • Previous quality engineering experience and demonstrated use of quality tools/methodologies.
  • Experience working in a broader enterprise/cross-division business unit model.

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

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:
HF Heart Failure

LOCATION:
United States > Burlington: 23 Fourth Avenue

ADDITIONAL LOCATIONS:
United States > Pleasanton : 6101 Stoneridge Dr

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)

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.

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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.

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
Net Income
$4.4 billion
Founded
1944
5 Year Trend
+15.6%
Revenue
$34.6 billion
NASDAQ

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