Senior Software Design Assurance Engineer

Regulatory Toolkit; Burlington (MA); Sur place; USD 78 000 - 156 000; Plein temps

Avantages offerts par ce poste

Free medical coverage (HIP)

Retirement savings plan

Tuition reimbursement

Education benefit (FreeU)

Student debt program

Diversity and inclusion programs

Résumé du poste

Abbott is seeking a Senior Software Design Assurance Engineer to support product development and maintain software quality engineering methodologies. This role focuses on software quality but may support other product development aspects based on experience.

Responsibilities include guiding software requirements, overseeing verification/validation, leading risk assessments, and ensuring compliance with FDA and other regulatory requirements.

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.

Responsabilités

• Provides technical and quality system guides related to establishing software requirements.
• Quality oversight for software verification and validation activities for new products.
• Leads meetings to prioritize and address issues in problem resolution systems during development.
• Leads risk evaluation and mitigation of software issues (e.g., FMEA, risk analysis).
• Participates in technical and management reviews to ensure design outputs meet requirements.
• Provide quality oversight for non-product software validation and related documentation.
• May assist with cybersecurity assessments with cross-functional team.
• Complies with FDA/regulatory requirements and company policies.
• Maintains cross-functional partnerships, especially with R&D.
• Works as individual contributor or mentor to QE team.
• Develops and conducts training for divisional software development/validation.
• Supports audits and drives quality system improvement activities.

Connaissances

Quality engineering

Regulatory knowledge

Software quality assurance

Communication skills

Formation

Bachelor’s degree in engineering or technical field

Advanced degree

Description du poste

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.

JOB DESCRIPTION:

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, 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.

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.

Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott, and on Twitter @AbbottNews.

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

EBIT is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf

EBIT is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf

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.

JOB FAMILY:

Operations Quality

DIVISION:

HF Heart Failure

LOCATION:

United States > Burlington: 23 Fourth Avenue

ADDITIONAL LOCATIONS:

United States > Pleasanton : 6101 Stoneridge Dr

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)