Senior Software Quality Design Engineer

The Opportunity

This position works out of our Westford, MA location in the Abbott Vascular Division.Our medical devices 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.

WHAT YOU'LL DO

• 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

• 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 6+ years of combined experience in software design quality, cybersecurity design quality is REQUIRED
• Medical Devices experience in Software is REQUIRED
• Experience with ISO 14971 is REQUIRED
• FMEA experience is REQUIRED

WHAT WE OFFER :

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

• A fast-paced work environment where your safety is our priority
• 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
5 days ago