Abbott

Software Design Quality Engineer

Abbott • $61K — $122K *
Westford, MA 01886In-Person
Healthcare
Less than 5 years of experience
Reposted 2 days ago
Be an Early Applicant
Job Overview by Ladders

Qualifications

  • Bachelor's degree in Computer Science, Biomedical Engineering, Software Engineering, or related field.
  • 2-5 years of experience in software design quality and cybersecurity design quality.
  • Familiarity with Agile methodology and experience in Agile SDLC projects.
  • Knowledge of industry standards (GMP, 21 CFR part 820, IEC 62304).
  • Experience with software configuration and issue tracking tools like Jira and Jama.

Responsibilities

  • Lead and support the execution of Quality Engineering deliverables from concept to commercialization.
  • Guide the development of standard operating procedures and test procedures.
  • Manage CAPA processes, including root cause analysis and corrective actions.
  • Coach team members on design quality best practices and agile testing.
  • Participate in reviews of software requirements and design, ensuring quality compliance.

Benefits

  • Health and wellness benefits for you and your family.
  • Opportunities for career development and growth within the company.
Full Job Description
Job Title

Software Design Quality Engineer

THE OPPORTUNITY

We currently have an opening for a Software Design Quality Engineer for the Vascular division. This role is located at our Westford, MA location. This is a fully onsite role.

Abbott Vascular provides innovative, minimally invasive and cost-effective products for treatment of vascular disease. Our extensive portfolio includes drug-eluting stents, bare metal stents, guide wires, balloon dilatation catheters, imaging catheters and software, vessel closure devices and peripheral stents.

MAIN RESPONSIBILITIES
  • Lead, execute and support on-time completion of Quality Engineering deliverables from product concept through commercialization, including but not limited to risk management activities (RMF, FMEA, Cybersecurity Risk Assessment)
  • Support on-time execution of Quality Plans
  • Guide development and documentation of standard operating procedures, specifications and test procedures
  • Support product recertifications
  • CAPA management - including (but not limited to) performing thorough investigations with detailed root-cause analyses with established methods (Fishbone, 5 Why), implementing corrections, corrective actions, creating and monitoring effectiveness criteria.
  • Work within Agile software development lifecycle framework
  • Support usability and human factors engineering reviews
  • Coach and mentor team members on best practices in design quality, and overall product lifecycle testing/quality engineering to establish product and system reliability. Accent on agile testing and automated testing practices
  • Participate in reviews for System and Software requirements, Software and Firmware design, and code inspection
  • Review and approve test methods, protocols and test results provided by another functional group.
  • Support activities related to software change management and overall change management
  • Bring forth ideas supporting continuous improvement and implement quality initiatives that measurably enhance medical device software and cybersecurity lifecycle activities
  • Support all activities, as needed by the business within the software development lifecycle.
  • Ensure DHF content completion, integrity, and regulatory & standards compliance; collaboratively communicating & resolving gaps
  • Support internal & external audit and related responses
  • Support the establishment of objective, measurable and verifiable customer and product requirements
  • Complete document Change Request reviews in a timely and objective manner
  • Additional duties may be identified by functional management based on the current project/business objectives.
  • Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
  • Comply with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintain positive, cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
  • Perform other related duties and responsibilities, on occasion, as assigned.


EDUCATION AND EXPERIENCE YOU'LL BRING

REQUIRED EXPERIENCE
  • Bachelor level degree in Computer science, biomedical engineering, software engineering or a closely related discipline or an equivalent combination of education and work experience.
  • Minimum of 2-5+ years of combined experience in software design quality, cybersecurity design quality
  • Experience ensuring automation frameworks and scripts meet design control requirements
  • Experience with software configuration, and issue tracking tools and requirements tools such as Jira and Jama
  • Experience as team-member/lead in Agile SDLC projects/programs
  • Deep knowledge of various types of SDLC's (V-Model, Iterative, Agile/Scrum, etc.)
  • Experience working in a broader enterprise/cross-site business unit model
  • Working knowledge of GMP, 21 CFR part 820, IEC 62304, ISO 14971, and ISO 13485
  • Ability to work in a highly matrixed and geographically diverse business environment.
  • Ability to work within a team and as an individual contributor in a fast-paced, changing environment
  • Ability to work in a lab, and hands-on experience with medical device development
  • Ability to leverage and/or engage others to accomplish projects
  • Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization
  • Ability to multitask, prioritize and meet deadlines in timely manner
  • Strong organizational and follow-up skills, as well as attention to detail


PREFERRED EXPERIENCE
  • Master's level degree preferred
  • ASQ CSQE and ISTQB certifications desired
  • Experience working with test management tools such TestComplete, desired
  • Experience in code review/static analysis tool(s) to aide code review such as Coverity, desired
  • Programming experience in C/C#/Visual Studio/Java, Scripting Language such as Python, Ruby, Perl, desired
  • Clinical/Hospital experience desired
  • Experience in software testing and verification/validation, including lead experience, desired


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
$61,300.00 - $122,700.00
In specific locations, the pay range may vary from the range posted.

JOB FAMILY:
Operations Quality

DIVISION:
AVD Vascular

LOCATION:
United States > Massachusetts > Westford : 4 Robbins Road

ADDITIONAL LOCATIONS:

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.

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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