Software Quality Engineer, Cybersecurity Compliance

The Opportunity

This position works at our Westford, MA location in the Abbott Vascular Division. Abbott Vascular provides innovative, minimally invasive, and cost-effective products for the treatment of vascular disease. This role is fully onsite.

Main Responsibilities

• Support Quality Engineering deliverables throughout the product lifecycle, including ownership of risk management activities, including cybersecurity risk management.
• Guide development and documentation of standard operating procedures, specifications and test procedures.
• Support product recertifications.
• Review and document outputs from cybersecurity threat model analyses conducted by the Cybersecurity team, ensuring traceability and compliance with quality and design control requirements.
• Review, track, document, and facilitate resolution of product vulnerability notifications and cybersecurity alerts provided by the Cybersecurity team.
• 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.
• 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.
• Support activities related to software change management and overall change management.
• 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.
• Perform external standard and regulation assessments. Identifying quality system gaps if any and creating resolution and implementation plans, tracking progress to closure.
• 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.

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 2-5 years of experience in software quality engineering, design quality, medical device quality systems, software validation, or cybersecurity quality/compliance activities.
• Experience in Design Controls for Class II medical device.
• 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.
• Leverage and/or engage others to accomplish projects.
• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
• 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.