Philips

4 days ago

Product Safety Quality Engineer

✓ Verified Job

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

Source: Company careers pageValidated by: Fursa AI

Last checked: 11 hours agoStatus: Live

Job Summary

Evaluate hospital patient monitoring product designs for safety concerns and hazards, ensuring thorough, accurate safety and compliance documentation aligned with regulatory standards and internal policies. Apply risk assessment methodologies including FMEA and FTA, perform comprehensive safety reviews, and identify risks impacting reliability and compliance. Work independently while using systematic methods to analyze and mitigate safety issues, and influence cross-functional stakeholders with risk management expertise.

Location: Cambridge, Orlando

Workplace: Onsite

Employment Type: Full time

Job Function: QA, Test & Release Engineering

Seniority: Mid level

Key Responsibilities

•Evaluate product designs to uncover safety concerns and potential hazards.
•Apply advanced risk assessment tools, including Failure Mode and Effects Analysis (FMEA) and Fault Tree Analysis (FTA).
•Perform comprehensive reviews to ensure product safety is thoroughly addressed.
•Identify and document risks that could impact reliability and compliance.
•Use systematic methodologies to analyze and mitigate safety issues in hospital patient monitoring products.

Pay and Benefits

Salary: USD 103,000 - 163,000 annually

Equity and Bonus:Equity

Perks:Paid Leave401kHsaEquity

Key Requirements

•2+ years of experience (Bachelor’s) or some Master’s experience in DFMEA, product quality, and risk management analysis/documentation in the medical device industry (5+ years strongly preferred).
•Strong knowledge of relevant regulations and standards including ISO 13485, ISO 14971, IEC 62304, and 82304.
•Strong knowledge of FMEA and risk management activities, Design for Quality (DFQ), and root cause analysis methods.
•Ability to perform the required physical, cognitive, and environmental job requirements with or without accommodation.
•Excellent communication skills and ability to influence cross-functional stakeholders using risk management expertise.

Experience:2+ yearsMedical device industry

Education:Bachelor's

Skills:CommunicationRisk managementStakeholder influenceRoot cause analysisIndependent work

Tech Stack:FMEAFault Tree Analysis (FTA)DFMEADFQRisk assessmentISO 13485ISO 14971IEC 62304IEC 82304Root cause analysis

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

Loading job details...

Preparing the role view and application actions.

Philips

4 days ago

Product Safety Quality Engineer

✓ Verified Job

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

Source: Company careers pageValidated by: Fursa AI

Last checked: 11 hours agoStatus: Live

Job Summary

Location: Cambridge, Orlando

Workplace: Onsite

Employment Type: Full time

Job Function: QA, Test & Release Engineering

Seniority: Mid level

Key Responsibilities

•Evaluate product designs to uncover safety concerns and potential hazards.
•Apply advanced risk assessment tools, including Failure Mode and Effects Analysis (FMEA) and Fault Tree Analysis (FTA).
•Perform comprehensive reviews to ensure product safety is thoroughly addressed.
•Identify and document risks that could impact reliability and compliance.
•Use systematic methodologies to analyze and mitigate safety issues in hospital patient monitoring products.

Pay and Benefits

Salary: USD 103,000 - 163,000 annually

Equity and Bonus:Equity

Perks:Paid Leave401kHsaEquity

Key Requirements

•2+ years of experience (Bachelor’s) or some Master’s experience in DFMEA, product quality, and risk management analysis/documentation in the medical device industry (5+ years strongly preferred).
•Strong knowledge of relevant regulations and standards including ISO 13485, ISO 14971, IEC 62304, and 82304.
•Strong knowledge of FMEA and risk management activities, Design for Quality (DFQ), and root cause analysis methods.
•Ability to perform the required physical, cognitive, and environmental job requirements with or without accommodation.
•Excellent communication skills and ability to influence cross-functional stakeholders using risk management expertise.

Experience:2+ yearsMedical device industry

Education:Bachelor's

Skills:CommunicationRisk managementStakeholder influenceRoot cause analysisIndependent work

Tech Stack:FMEAFault Tree Analysis (FTA)DFMEADFQRisk assessmentISO 13485ISO 14971IEC 62304IEC 82304Root cause analysis

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