Senior Design Quality Engineer

Job Description

The Senior Design Quality Engineer is accountable for system/hardware design quality and risk management throughout the product life cycle for Philips Sleep & Respiratory Care products.

Job Title:

Senior Design Quality Engineer

• Ensures that appropriate quality plans are made that include all stages of the life cycle of the product and supports Quality Plan design
• Provides independent oversight of the design input process, design V&V activities, design transfer and product realization, and performance in the field to ensure that all design requirements are effectively met
• Validates key design inputs: usability, reliability, performance, supportability, manufacturability, localizability, safety, security, privacy, serviceability, sustainability and costs
• Provides effective oversight of the execution of the Quality Plan, any Risk Management activities and of all design related activities during the product/system lifecycle
• Performs independent technical assessment on product quality performance and post‑market product quality analysis; provides analytics to the Business on the efficacy and efficiency of the design and product realization processes
• Performs post‑market data analysis/statistics to report on product quality performance in the field and to the Business on the efficacy and efficiency of the design and product realization processes
• Initiates field actions/CAPA when required

• Minimum of 5+ years’ experience in FDA regulated medical device environments, with a focus on Design Assurance/Control and strong understanding of ISO 13485 / 9001 / FDA / Canada
• Proven experience/knowledge in Risk Management (ISO 14971), FMEA/DFMEA, Design Verification/Validation, Root Cause analysis and Defect Management
• Detailed experience in identifying, promoting and supporting processes and design quality tools for use in tracking/preventing product defects, design traceability, and Design for Reliability
• Experience in utilizing post‑market surveillance (PMS) insights/data analytics to lead continuous improvement throughout all stages of the product lifecycle
• Ability to share knowledge, insights regarding quality standards and regulatory requirements
• Minimum of a Bachelor’s Degree (Required), in Quality, Engineering or similar disciplines

The pay range for this position in Murrysville, PA is $92,000 to $146,000. The actual base pay offered may vary within the posted ranges depending on multiple factors including job‑related knowledge/skills, experience, business needs, geographical location, and internal equity

• Comprehensive Philips Total Rewards benefits program, which includes generous PTO, 401k (up to 7% match), HSA (with company contribution), stock purchase plan, education reimbursement and more
• Annual incentive bonus, sales commission or long‑term incentives may be offered

• Office‑based in Murrysville, PA; must reside in or within commuting distance to the location
• Office work required at least 3 days per week
• May require travel up to 10%
• US work authorization is a precondition of employment; sponsorship for work‑authorized visas not considered
• Company relocation benefits will not be provided for this position

Philips is an Equal Employment and Opportunity Employer including Disability/Vets and maintains a drug‑free workplace.