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.

About Abbott

For years, Abbott’s medical device businesses have offered technologies that are faster, more effective, and less invasive. Whether it’s glucose monitoring systems, innovative therapies for treating heart disease, or products that help people with chronic pain or movement disorders, our medical device technologies are designed to help people live their lives better and healthier. Every day, our technologies help more than 10,000 people have healthier hearts, improve quality of life for thousands of people living with chronic pain and movement disorders, and liberate more than 500,000 people with diabetes from routine fingersticks.

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

Our location in Westford, MA currently has an opportunity for a Staff Software Quality Engineer .

THIS IS AN ON-SITE DAILY POSITION.

WHAT YOU'LL DO

This position is a key technical leadership role, helping to ensure delivery of the highest quality product to the customer. This role is responsible for executing and maintaining product quality with a focus on software, driving business priorities and providing quality engineering support for software utilized throughout the division.

Key Behaviors for Success include:

• Translate Business strategy into actionable, aligned goals and measures

• Take initiative in gathering data to support strategic planning for future successes

• Drive innovation through a risk-based approach, balancing business need with compliance and Quality-first mindset

• Ability to influence peer group to deliver results with quality

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)

• Lead on-time execution of Quality Plans

• Lead and support 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, 6M), historical complaint analysis,implementing corrections, corrective actions, creating and monitoring effectiveness criteria.

• Work within Agile software development lifecycle framework

• 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

• May have direct reports

• Actively participate in various design control deliverable and change request reviews in a timely and objective manner including but not limited to System and Software requirements, Software and Firmware design, code inspection, usability, human factors engineering studies, test methods, protocols and test results

• 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

• Lead Product/Process improvement efforts by identifying methods to capture quality metric data and by identifying & performing appropriate analysis methods to enhance new product development.

• 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

• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving issues.

• Ability to work hands-on in a device lab environment

• 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.

• Performs other related duties and responsibilities, on occasion, as assigned.

Physical Demands:

Activities require a significant amount of sitting in front of a computer monitor, some standing and walking. Significant use of hands and arms, plus finger dexterity to reach, point, write, type, operate a computer and other office equipment. Performs tasks that regularly require good correctable vision and hand/eye coordination. Activities also require significant use of voice and hearing for discussions with other employees.

EDUCATION AND EXPERIENCE YOU'LL BRING

• 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 9 years Software Design Quality or Cybersecurity Design Quality in a medical device environment

• 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 and leader 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

• 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

• ASQ CSQE certification desired

• Ability to travel approximately 5-10%.

• Ability to maintain regular and predictable attendance

WHAT WE OFFER

• At Abbott, you can have a good job that can grow into a great career. We offer:

• Training and career development , with onboarding programs for new employees and tuition assistance

• Financial security through competitive compensation, incentives and retirement plans

• Health care and well-being programs including medical, dental, vision, wellness and occupational health programs

• Paid time off

• 401(k) retirement savings with a generous company match

• The stability of a company with a record of strong financial performance and history of being actively involved in local communities

Learn more about our benefits that add real value to your life to help you live fully: www.abbottbenefits.com (http://www.abbottbenefits.com/pages/candidate.aspx)

Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future.

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 $95,000.00 – $190,000.00. In specific locations, the pay range may vary from the range posted.

An Equal Opportunity Employer

Abbot welcomes and encourages diversity in our workforce.

We provide reasonable accommodation to qualified individuals with disabilities.

To request accommodation, please call 224-667-4913 or email corpjat@abbott.com