Job Directory Staff Quality Engineer (Software) - Westford, MA/Santa Clara, CA/Temecula, CA

Staff Quality Engineer (Software) - Westford, MA/Santa Clara, CA/Temecula, CA
Westford, MA

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Job Description

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 103,000 colleagues serve people in more than 160 countries.



Westford, MA

Santa Clara, CA

Temecula, CA


We are seeking an experienced, high caliber Staff Engineer, Development Quality. A development 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.

Impact this role will have on Abbott:

* 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

Lead Abbott Vascular cybersecurity quality engineering support 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 security projects.

Your experience(s), education and knowledge will further expand Abbott's marketplace success:

* Bachelor level degree in an Engineering Discipline
* 10+ years' 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

Your preferred qualifications and education:

* Advance degree
* Degree in Mechanical, Biomedical, or Electrical Engineering
* Prior medical device experience preferred BUT NOT REQUIRED.
* Cybersecurity Experience is preferred but not mandatory
* Team leadership experience
* R&D Experience
* Experience working in a broader enterprise/cross-division business unit model
* Working understanding of the following standards 60601, 14971, and 62304
* Strong background in medical device software quality


JOB FAMILY:Operations Quality


LOCATION:United States > Massachusetts > Westford : 4 Robbins Road

ADDITIONAL LOCATIONS:United States > Santa Clara : Building A - SC Floor-2, United States > Temecula : Building E - TE Floor-2


TRAVEL:Yes, 25 % of the Time


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)

Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.

EEO is the Law link - English:

EEO is the Law link - Espanol:

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