JOB DESCRIPTION:Job TitleSoftware 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.
What You'll Work On
You will support software quality and cybersecurity compliance activities for medical device products by reviewing security alerts, tracking risk mitigation activities, and maintaining required quality documentation. Working closely with Product Development, Quality, and Cybersecurity teams, you will help ensure compliance with design controls, regulatory standards, and company quality processes.
MAIN RESPONSIBILITIES
- Support Quality Engineering deliverables throughout the product lifecycle, including ownership of risk management activities, including cybersecurity risk management.
- Support on-time execution of Quality Plans
- 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.
- 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.
- 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.
- Perform other related duties and responsibilities, on occasion, as assigned.
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
- 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 NowLearn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com
Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life.
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)
