Philips

3 weeks ago

Quality Manager - Design Quality Engineering

✓ Verified Job

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

Source: Company careers pageValidated by: Fursa AI

Last checked: 14 hours agoStatus: Live

Job Summary

Lead a team of Design Quality Engineers as both a people manager and Design Quality SME. Guide project teams on Design Controls and related regulations, support engineering through the development lifecycle, and build advanced statistical approaches for EU-MDR Part 88, rare-event trending, and reliability modeling. Own post-market risk assessment, present findings for MT-level council review, and facilitate cross-functional Design FMEA (software and hardware).

Location: Cambridge, San Diego

Workplace: Onsite

Employment Type: Full time

Job Function: Quality & Regulatory (Non-Software)

Seniority: Manager level

Key Responsibilities

•Lead a team of Design Quality Engineers on Design Controls, related regulations, and internal processes.
•Act as a “Super User” interpreting the Design Controls process for business needs beyond specific projects.
•Support engineering development teams across the development lifecycle to ensure robust designs.
•Develop and apply advanced statistical tools for EU-MDR Part 88, rare-event trending, and product reliability modeling.
•Perform post-market risk assessment and facilitate Design Failure Modes Effects Analysis (FMEA) for cross-functional engineering teams (software and hardware).

Pay and Benefits

Salary: USD 120,000 - 186,000 annually

Perks:Paid Leave401kHsaEquity

Key Requirements

•Bachelor’s or Master’s degree in Mechanical Engineering, Industrial Engineering, Science, or equivalent.
•5+ years of relevant experience, including demonstrated leadership and people management.
•Strong mastery of quality principles including Quality System structure, CAPA, reliability, and root-cause investigation tools.
•Ability to teach and apply design quality concepts such as Verification vs. Validation, requirements development/decomposition vs. specification development, Safety Risk Management, and FMEA.
•Preferred experience with EU-MDR, 21CFR820, ISO 13485, ISO 14971/TS 24971, IEC 60601, IEC 62366, IEC 62304, and IEC 60812/VDA FMEA Handbook.

Experience:5+ yearsMedical devicesQualityDesign controlsRegulated industry

Education:Master's in Mechanical Engineering, Industrial Engineering, Science

Skills:LeadershipPeople managementMentoringRisk assessmentStatistical analysis

Certifications:ASQ CQEASQ CREASQ CQM

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

3 weeks ago

Quality Manager - Design Quality Engineering

✓ Verified Job

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

Source: Company careers pageValidated by: Fursa AI

Last checked: 14 hours agoStatus: Live

Job Summary

Location: Cambridge, San Diego

Workplace: Onsite

Employment Type: Full time

Job Function: Quality & Regulatory (Non-Software)

Seniority: Manager level

Key Responsibilities

•Lead a team of Design Quality Engineers on Design Controls, related regulations, and internal processes.
•Act as a “Super User” interpreting the Design Controls process for business needs beyond specific projects.
•Support engineering development teams across the development lifecycle to ensure robust designs.
•Develop and apply advanced statistical tools for EU-MDR Part 88, rare-event trending, and product reliability modeling.
•Perform post-market risk assessment and facilitate Design Failure Modes Effects Analysis (FMEA) for cross-functional engineering teams (software and hardware).

Pay and Benefits

Salary: USD 120,000 - 186,000 annually

Perks:Paid Leave401kHsaEquity

Key Requirements

•Bachelor’s or Master’s degree in Mechanical Engineering, Industrial Engineering, Science, or equivalent.
•5+ years of relevant experience, including demonstrated leadership and people management.
•Strong mastery of quality principles including Quality System structure, CAPA, reliability, and root-cause investigation tools.
•Ability to teach and apply design quality concepts such as Verification vs. Validation, requirements development/decomposition vs. specification development, Safety Risk Management, and FMEA.
•Preferred experience with EU-MDR, 21CFR820, ISO 13485, ISO 14971/TS 24971, IEC 60601, IEC 62366, IEC 62304, and IEC 60812/VDA FMEA Handbook.

Experience:5+ yearsMedical devicesQualityDesign controlsRegulated industry

Education:Master's in Mechanical Engineering, Industrial Engineering, Science

Skills:LeadershipPeople managementMentoringRisk assessmentStatistical analysis

Certifications:ASQ CQEASQ CREASQ CQM

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