Philips

10 hours ago

Sr. Software Design Assurance Engineer

✓ Verified Job

Canonical indexed version, validated from employer's careers page.

Source: Company careers pageValidated by: Fursa AI

Last checked: 10 hours agoStatus: Live

Job Summary

Support new product development and sustaining projects by leading software design verification from a software design quality assurance perspective for image guide therapy. Develop and review design verification plans, protocols, and reports; lead risk management artifacts for medical device software; and ensure ISO/IEC compliance (including ISO 14971 and IEC 62304). Serve as an SME, collaborate on code review and security analysis, manage defects/vulnerabilities, and drive best practices across software quality processes.

Location: Bengaluru

Workplace: Onsite

Employment Type: Full time

Job Function: Design (Product/UX/UI/Visual)

Seniority: Mid level

Key Responsibilities

•Develop and review software design verification plans, protocols, and reports; conduct design verification and develop/review quality plans.
•Lead and support development, design verification, and hypercare for non-product software assessments and qualification efforts.
•Create and review risk management files including risk management plans, product hazard analysis, FMEAs, software risk assessment, risk management matrix, and benefit-risk determination.
•Ensure risk management effectiveness using feedback from validation, field service, post-market surveillance, manufacturing indicators, CAPAs, and HHAs, with expertise in ISO 14971 and IEC 62304.
•Act as an SME for software design assurance; collaborate on code review, unit tests, software security analysis, defect/vulnerability triage, and creation/review of sBOMs while driving software quality best practices.

Pay and Benefits

Salary: USD 80,000 - 135,000 annually

Equity and Bonus:Equity

Perks:Paid Leave401kHsaEquityLearning Budget

Key Requirements

•B.S. or M.S. in a relevant engineering field (e.g., biomedical, computer science, software development, electrical).
•8+ years of experience in software quality and/or software development in the medical device industry with hands-on SW design verification and/or development.
•Expertise applying 21 CFR 820, ISO 13485, IEC 14971, and IEC 62304, and working knowledge of IEC 60601 and related medical device standards.
•Experience with software development lifecycle methodologies including Agile and SAFe.
•Experience with defect tracking/management tools (e.g., Jira or Clearquest), statistical software (e.g., JMP or Minitab), and requirements/traceability tools (e.g., JAMA, IBM DOORS).

Experience:8+ yearsMedical deviceAgileSAFe

Education:Master's

Skills:CollaborationRisk managementCode reviewDefect and vulnerability triage

Tech Stack:ISO 14971IEC 62304IEC 6060121 CFR 820ISO 13485IEC 62304 Medical Device SoftwareAgileSAFeJiraClearquestJMPMinitabJAMAIBM DOORSSBOMFMEAsFMEACAPAsHHAsRisk management matrix

Eligibility

Work Authorization:Authorization required. Sponsorship not provided.

Company Brief

Philips

Global health technology company focusing on diagnostic imaging, patient monitoring, and consumer health products. Philips develops medical devices, healthcare informatics, and solutions to improve patient care and personal well-being.

Industry: HealthTech

Company Size: Enterprise (1,001+ employees)

Revenue: USD 1B+

Growth: Public Company

Valuation: Public Company (Market Cap in USD)

Funding: IPO / Publicly Listed

Headquarters: Amsterdam, Netherlands

Founded: 1891

Glassdoor: 3.8

Website LinkedIn

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Philips

10 hours ago

Sr. Software Design Assurance Engineer

✓ Verified Job

Canonical indexed version, validated from employer's careers page.

Source: Company careers pageValidated by: Fursa AI

Last checked: 10 hours agoStatus: Live

Job Summary

Location: Bengaluru

Workplace: Onsite

Employment Type: Full time

Job Function: Design (Product/UX/UI/Visual)

Seniority: Mid level

Key Responsibilities

•Develop and review software design verification plans, protocols, and reports; conduct design verification and develop/review quality plans.
•Lead and support development, design verification, and hypercare for non-product software assessments and qualification efforts.
•Create and review risk management files including risk management plans, product hazard analysis, FMEAs, software risk assessment, risk management matrix, and benefit-risk determination.
•Ensure risk management effectiveness using feedback from validation, field service, post-market surveillance, manufacturing indicators, CAPAs, and HHAs, with expertise in ISO 14971 and IEC 62304.
•Act as an SME for software design assurance; collaborate on code review, unit tests, software security analysis, defect/vulnerability triage, and creation/review of sBOMs while driving software quality best practices.

Pay and Benefits

Salary: USD 80,000 - 135,000 annually

Equity and Bonus:Equity

Perks:Paid Leave401kHsaEquityLearning Budget

Key Requirements

•B.S. or M.S. in a relevant engineering field (e.g., biomedical, computer science, software development, electrical).
•8+ years of experience in software quality and/or software development in the medical device industry with hands-on SW design verification and/or development.
•Expertise applying 21 CFR 820, ISO 13485, IEC 14971, and IEC 62304, and working knowledge of IEC 60601 and related medical device standards.
•Experience with software development lifecycle methodologies including Agile and SAFe.
•Experience with defect tracking/management tools (e.g., Jira or Clearquest), statistical software (e.g., JMP or Minitab), and requirements/traceability tools (e.g., JAMA, IBM DOORS).

Experience:8+ yearsMedical deviceAgileSAFe

Education:Master's

Skills:CollaborationRisk managementCode reviewDefect and vulnerability triage

Tech Stack:ISO 14971IEC 62304IEC 6060121 CFR 820ISO 13485IEC 62304 Medical Device SoftwareAgileSAFeJiraClearquestJMPMinitabJAMAIBM DOORSSBOMFMEAsFMEACAPAsHHAsRisk management matrix

Eligibility

Work Authorization:Authorization required. Sponsorship not provided.

Company Brief

Philips

Industry: HealthTech

Company Size: Enterprise (1,001+ employees)

Revenue: USD 1B+

Growth: Public Company

Valuation: Public Company (Market Cap in USD)

Funding: IPO / Publicly Listed

Headquarters: Amsterdam, Netherlands

Founded: 1891

Glassdoor: 3.8

Website LinkedIn