Senior Software Design Assurance Engineer

RXinsider LTD.; Burlington (MA); On-site; USD 78,000 - 156,000; Full time

Benefits offered by this job

Health benefits

Equal opportunity employer

Job summary

Abbott in the United States is seeking a Senior Software Design Assurance Engineer to support software development and apply quality engineering methods across design and validation. You will review software test protocols, development plans, and documentation, and lead risk assessments (e.g., FMEA) with cross‑functional teams.

The role emphasizes validation activities, cybersecurity considerations, and compliance with US FDA regulations.

Qualifications

• Bachelor’s degree in engineering or a technical field.
• Minimum of 5 years related work experience in Quality or a related field.
• Knowledge of regulations, standards, and guidance affecting medical software and non-medical device software development.
• Strong verbal and written communication with the ability to effectively communicate at multiple levels in the organization.

Responsibilities

• Provides technical and quality system guides related to software requirements.
• Review software test protocols, development plans, and reports for approval.
• Leads meetings to prioritize actions addressing issues captured in problem resolution systems.
• Leads risk evaluation and mitigation including FMEA and product risk analysis.
• Participates in reviews to ensure software deliverables meet design outputs.
• Ensures non-product software validation needs are identified and documented.
• Supports cybersecurity assessments with cross-functional teams.
• Maintains compliance with FDA regulations and company policies.
• Develops training for personnel on software development and validation.
• Supports audits and quality system improvement initiatives.

Skills

Quality engineering

Risk assessment

Regulatory knowledge

Communication skills

Education

Bachelor’s degree in engineering or a technical field

Advanced degree

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 115,000 colleagues serve people in more than 160 countries.

At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to :

• Career development with an international company where you can grow the career you dream of.
• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• An excellent retirement savings plan with high employer contribution
• Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.
• A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
• A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity

The Senior Software Design Assurance Engineer is responsible for supporting product development, executing and maintaining software quality engineering methodologies, and providing quality engineering support for software. The Senior Software Design Assurance Engineer position focuses primarily on software quality but also supports other aspects of product development based on experience.

What You’ll Work On

• Provides technical and quality system guides related to establishing software requirements.
• Provide quality oversight for software verification and validation activities for new products in accordance with design planning procedures. This includes, but is not limited to, reviewing and approving software test case protocols and reports, reviewing software development plans, and reviewing other system and software documentation.
• Leads meetings to prioritize, review, and/or approve action plans for addressing issues captured in problem resolution systems during development.
• Leads risk evaluation and associated management activities related to software development, including Risk assessments (e.g., FMEA), product risk analysis, and mitigation of software issues.
• Participates in technical and management reviews to ensure design plans, product design, and deliverables related to product software are met. Represent the quality engineering function for the review and approval of designated design outputs.
• Provide quality oversight for non-product software validation by assessing the need for validation and preparing and/or supporting protocols, reports, and other documentation as required.
• May be involved with supporting product cybersecurity assessments in conjunction with a cross-functional team
• Complies with US FDA regulations, other country regulatory requirements, company policies, and procedures.
• Maintains a strong, collaborative partnership with cross-functional team members, especially with R&D.
• Works as an individual contributor and may provide guidance or oversee the work of other QE team members.
• Develop and conduct training of company personnel for the divisional software development and validation program.
• Support audits and lead quality system improvement activities.
• Additional responsibilities may be assigned as needed.

Required Qualifications

• Bachelor’s degree in engineering or a technical field
• Minimum of 5 years related work experience in Quality or a related field.
• Knowledge of regulations, standards, and guidance affecting medical software and non-medical device software development.
• Strong verbal and written communication with the ability to effectively communicate at multiple levels in the organization.

Preferred Qualifications

• Advanced degree
• Previous quality engineering experience and demonstrated use of quality tools/methodologies.
• Experience working in a broader enterprise/cross-division business unit model.

Learn 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. Abbott is an Equal Opportunity Employer, committed to employee diversity.

The base pay for this position is $78,000.00 - $156,000.00. In specific locations, the pay range may vary from the range posted.