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 109,000 colleagues serve people in more than 160 countries.

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 Cybersecurity Quality Engineer. This position will lead Abbott Vascular cybersecurity quality engineering activities by developing and maintaining cybersecurity policy, standards, applications, systems, etc. Develop a risk-based cyber security program which meets regulatory requirements and aligns with industry leading information security practices. Work closely with R&D software engineers on threat identification and mitigation activities using industry leading security controls and tools sets. Collaborate with business units, application development teams, and third-party vendors to achieve program requirements while enabling the business. Facilitate cross team coordination to achieve defined security goals as well as meet technical requirements in support of detailed implementation plans for cybersecurity projects.

We are seeking an experienced, high caliber Staff Cybersecurity Quality Engineer. A quality engineer assures new or modified products conform to requirements and establish compliance with the quality system.  This position is responsible for maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success by protecting patient/user safety and meeting business needs. Each employee can make a difference at Abbott and has the power, either individually or as a team, to influence the success of the company. We are team-oriented, fast-paced and progressive. We value people with great ideas who partner with others both internally and externally to take action and accomplish goals.

WHAT YOU’LL DO

• Execution and on-time completion of design control deliverables
• Design verification and validation test planning and execution
• Design verification and validation test protocols and reports
• Design input output trace matrix
• Quality Planning, including internal product development, OEM-based, Clinical Product Development (CPDP), and design change projects
• Ensure DHF content completion, integrity, and regulatory & standards compliance; collaboratively communicating & resolving gaps
• Requirements review
• Regulatory responses and submissions
• Lead Risk Management activities from product Concept through Commercialization 
• Design specification reviews
• Design change plan/reports
• Internal and external audit findings and responses
• Corrective and preventive action resolution
• Change requests
• Ability to work independently with minimal/no supervision
• Ability to coach/mentor junior and/or entry-level Engineering personnel/staff
• Maintain high standards for content completion, integrity, and regulatory & standards compliance; collaboratively identifying, communicating & resolving gaps
• Comply with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, company policies, operating procedures, processes, and task assignments
• Maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors
• Support all Divisional initiatives as identified by divisional management and in support of quality management systems (QMS), environmental management systems (EMS), and other regulatory requirements
• Perform other duties and responsibilities as assigned by functional management based on the current project/business objectives including 10% travel, including international travel and regular predictable attendance

EDUCATION AND EXPERIENCE YOU’LL BRING

Required

Minimum 8 years:

• Bachelor level degree in an Engineering Discipline or an equivalent combination of education and work experience
• Cybersecurity background and experience
• Previous Quality engineering experience and demonstrated use of Quality tools/methodologies
• Working understanding of FDA, GMP, and ISO 13485
• Solid verbal, written, and interpersonal skills with ability to effectively communicate at multiple levels in the organization
• Ability to leverage and/or engage others to accomplish projects.
• Multitasks, prioritizes and meets deadlines in timely manner
• Ability to work both within a team, and independently, in a fast-paced, changing environment
• Project management experience

Preferred

• Advance degree
• 10+ years’ experience
• Prior medical device and quality engineering experience preferred
• Degree in Mechanical, Biomedical, or Electrical Engineering
• Team leadership experience
• Experience working in a broader enterprise/cross-division business unit model
• Working understanding of the following standards 60601, 14971, &/or 62304

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

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.