Senior Design Assurance Engineer

Role Overview

The Senior Design Assurance Engineer will support the design controls process, focusing on Sustaining and New Product Development (NPI) of Philips' Image Guided Therapy Devices (IGTD).

Responsibilities

• Ensures Risk Management is effective through 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.

Requirements

• A 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) and strong Understanding of all aspects of the QMS related to Design/Process Controls.
• 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.
• A minimum of a bachelor’s degree in Quality, Engineering (Mechanical, Chemical, Biomedical) or a related Scientific discipline (required).
• ASQ certifications (desired).

Qualifications

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

Benefits

Details about our benefits can be found here. Details about our pay range can be found here.