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Philips · 16 hours ago

Senior Design Assurance Engineer

Plymouth, MN

Full-time

Onsite

Mid, Senior Level

$91K/yr - $146K/yr

5+ years exp

Philips is a health technology company dedicated to providing quality healthcare to everyone. The Senior Design Assurance Engineer will support the design controls process for new product development and sustaining products, ensuring effective risk management and compliance with quality system regulations.

B2BConsumer ElectronicsElectronicsLightingWellness

No H1B

Responsibilities

Ensures Risk Management is effective utilizing feedback from validation, field service, post market surveillance, manufacturing indicators, CAPAs, HHAs, and updating risk documents, component qualification, statistical analysis of data, design verification and process validation planning as well as quality system compliance

Provides critical quality review of design requirement rationales, test methods, training requirements and test method validation requirements

Determines and recommends sampling plans, equipment requirements, measurement techniques and training requirements that will ensure specific quality levels

Works with cross functional teams to complete component qualification activities, plan/conduct design verification (DVT) and process validation activities

Participates in the development/results analysis of verification and validation (V&V) plans and test protocols to qualify and validate new product designs and processes

Qualification

Design AssuranceRisk ManagementMedical Device QSRStatistical AnalysisComponent QualificationQuality System ComplianceASQ CertificationsBachelor's DegreeCross Functional Collaboration

Required

Minimum of 5+ years' experience in FDA regulated medical device environments, with a focus on Design Assurance/Control

Detailed knowledge of Risk Management (ISO 14971)

Strong understanding of all aspects of the QMS related to Design/Process Controls

Strong understanding of Medical Device QSR regulations/standards including ISO 13485, ISO 14971, 21CFR (803, 806, 820, etc.), MDD/ EU MDR

Ability to analyze quality data and draw conclusions regarding trending, KPI's etc

Extensive experience supporting the creation and review of all medical device documentation including- Component qualification, Design Verification Test/regression plans, test protocols/reports, process validation, issue tracking/resolution and auditing Design History Files (DHF)

Proven ability to cultivate and maintain strong relationships with team members and internal/external stakeholders

Minimum of a bachelor's degree in Quality, Engineering (Mechanical, Chemical, Biomedical) or a related Scientific discipline

Must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position

US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future

Company relocation benefits will not be provided for this position. For this position, you must reside in or within commuting distance to Plymouth, MN