Software Design Assurance Eng

Philips
United States
Workplace: OnsiteFull timeUSD 102,480 - 163,968 annuallyFunction: Design (Product/UX/UI/Visual)Experience: 5+ yearsEducation: bachelorsSkills: ["Communication","Problem-solving","Leadership"]

Lead assessment and validation of medical device software designs to uphold quality, safety, and regulatory standards across the software lifecycle. Drive compliance with FDA/regulatory requirements (IEC 62304, ISO 14971), risk management, software verification, traceability, and cybersecurity risk management, while coordinating root cause analysis and post-market monitoring.

Loading

Loading job details...

Preparing the role view and application actions.

FursaFursa
Philips
Philips
3 months ago

Software Design Assurance Eng

✓ Verified Job

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

Source: Company careers pageValidated by: Fursa AI
Last checked: 32 days agoStatus: Live

Job Summary

Lead assessment and validation of medical device software designs to uphold quality, safety, and regulatory standards across the software lifecycle. Drive compliance with FDA/regulatory requirements (IEC 62304, ISO 14971), risk management, software verification, traceability, and cybersecurity risk management, while coordinating root cause analysis and post-market monitoring.
Location: United States
Workplace: Onsite
Employment Type: Full time
Job Function: Design (Product/UX/UI/Visual)

Key Responsibilities

  • •Leads the assessment of software designs by reviewing test and performance data to uphold quality, safety, and regulatory standards, and address any engineering deficiencies.
  • •Lead in the effective application, compliance, and continuous improvement of policies, procedures, and practices related to software development and validation including- Software design/verification, Risk management, Systems validation, Traceability and Cyber security risk management.
  • •Track and risk assess software Anomalies for pre- and post-market medical device software.
  • •Conducts detailed root cause analyses for software quality issues and validating key design inputs like usability, reliability, and performance.
  • •Assess products and systems to identify defects, abnormalities and design flaws by authoring and executing software test protocols and generating test reports.
Travel: Low travel

Pay and Benefits

Salary: USD 102,480 - 163,968 annually

Key Requirements

  • •Minimum 5+ years experience in FDA-regulated, IEC 62304 medical device software environments, focusing on Software Design Assurance/Control, risk management (ISO 14971), SDLC, and QMS related to Software Design Controls.
Experience:5+ yearsMedical devicesRegulated
Education:Bachelor's in Quality, Computer Science/Engineering or similar
Skills:CommunicationProblem-solvingLeadership
Certifications:ISTQB
Languages:English
Tech Stack:CC++C#

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
Glassdoor: 3.8
WebsiteLinkedIn