Senior Design Assurance Quality Engineer

Job Title

Senior Design Assurance Quality Engineer

Job Description

The Senior Design Assurance Quality Engineer is responsible for executing all functions of Design Assurance & Hardware/Software Quality Engineering, ensuring Philips’ Ambulatory Monitoring & Diagnostics (AM&D) products are compliant with all applicable internal, domestic, and international quality regulations.

Your Role:

• Executes all functions of Design Assurance & Hardware/Software Quality Engineering in compliance with all applicable internal, domestic, and international quality regulations, US 21 CFR 820 (QSR), ISO 13485, ISO 14971, ISO10993, ISO14971, IEC 60601, IEC 62304/82304 etc.
• Provides guidance for hardware and software product development under Design Controls and AGILE Software Development Life Cycle processes: User and Product requirements, Functional Specifications, Configuration Management, Design Verification/Validation, Design Reviews, Pre- and Post-Market Product Changes and Defect Tracking and Management.
• Ensures product safety risk management deliverables are created, maintained, and stored in the Risk Management file throughout the product life. Monitors and reports on the product’s safety risk management performance in the field and ensure deliverables are updated as needed.
• Partners with R&D, Medical Safety, Operations, and other departments within the organization. 

You're the right fit if:

• You have a minimum of 7+ years’ experience focused on Design Quality Engineering/Assurance within FDA regulated (ISO 13485) product environments, with proven experience implementing design controls throughout the product life cycle. Experience with wearable/implantable Cardiac Care/Monitoring devices highly desired.
• You have strong experience in Design Control, Risk Management (ISO 14971), User/ Product requirements, Functional Specifications, Configuration Management, Design Verification/Validation/Reviews, Pre/Post-Market product changes and Defect Tracking/Management.
• You have a proven track record in roles of increasing responsibility, impact, and scope within a manufacturing/new product development/R&D (hardware and software) medical device environment. 
• You’re experienced in AGILE Software Development Life Cycle process and document generation. 
• You have strong knowledge of medical device regulations (FDA 21 CFR 820, FDA 21 CRF Part 11, ISO 13485, ISO10993, ISO14971, IEC 60601, IEC 62304)
• You’ve displayed excellent organizational and interpersonal skills working in cross-functional teams.
• You have a Minimum of a Bachelor’s Degree (Required) in a Quality discipline, Engineering, Clinical/Life Science or similar disciplines. Master’s Degree desired.
• You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position. 

How we work together:

We believe that we are better together than a part. For our Office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the company’s facilities. Field roles are most effectively done outside of the company’s main facilities, generally at the customers’ or suppliers’ locations. This is an Office role.

About Philips:

We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality. healthcare that we all deserve. Do the work of your life to help improve the lives of others.

• Learn more about our business.
• Discover our rich and exciting history.
• Learn more about our purpose.
• Learn more about our commitment to diversity and inclusion.

Philips Transparency Details:

• The pay range for this position in Malvern, PA is $120,000 to $192,000.
• The pay range for this position in San Diego, CA is $128,000 to $205,000.

The actual base pay offered may vary within the posted ranges depending on multiple facto