Medical Device Software Quality Engineer – Onsite Westford

Abbott Laboratories; Westford, Northern (MA, KY); Hybrid; USD 61,000 - 123,000; Full time

Job summary

Abbott Laboratories seeks a Software Design Quality Engineer for its Westford, MA site to drive quality engineering deliverables across the software lifecycle. You will lead risk assessments, CAPA, and regulatory compliance while collaborating with cross-functional teams in an on-site, fast-paced environment.

The role emphasizes agile testing, automated testing practices, and hands-on medical device software development.

Qualifications

• Bachelor level degree in Computer science, biomedical engineering, software engineering or an equivalent combination of education and work experience.
• Minimum of 2-5+ years of combined experience in software design quality, cybersecurity design quality
• 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

Responsibilities

• Lead, execute and support on-time completion of Quality Engineering deliverables from product concept through commercialization.
• Support on-time execution of Quality Plans
• Guide development and documentation of SOPs, specifications and test procedures
• Support product recertifications
• CAPA management with root-cause analyses and corrective actions
• 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 testing
• Review and approve test methods, protocols, and test results
• Support software change management activities and overall change management
• Ensure DHF content completion, integrity, and regulatory compliance
• Support internal & external audits and responses
• Complete Change Requests timely and objectively
• Contribute to continuous improvement and quality initiatives
• Collaborate across functions to support regulatory requirements

Skills

Quality Engineering

Cybersecurity

Agile SDLC

Jira

Jama

C/C++

Java

Python

Education

Bachelors in Computer Science / Biomedical Engineering / Software Engineering

Master’s degree preferred

Tools

TestComplete

Coverity

Job description

Abbott Laboratories seeks a Software Design Quality Engineer for its Westford, MA site to drive quality engineering deliverables across the software lifecycle. You will lead risk assessments, CAPA, and regulatory compliance while collaborating with cross-functional teams in an on-site, fast-paced environment.

The role emphasizes agile testing, automated testing practices, and hands-on medical device software development.