Senior Design Quality Engineer

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.

Your role:

• Ensuresthat 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 effectiveoversight 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.

Youre the right fit if:

• You have a 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
• You have proven experience/knowledge in Risk Management (ISO 14971) FMEA/DFMEA Design Verification/Validation Root Cause analysis and Defect Management.
• You have 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.
• Youre experienced in utilizing Post Market Surveillance (PMS) insights/data analytics to lead continuous improvement throughout all stages of the product lifecycle.
• Youre able to share knowledge insights regarding quality standards and regulatory requirements.
• You have a minimum of a Bachelors Degree (Required) in Quality Engineering or similar disciplines.
• 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 companys facilities. Field roles are most effectively done outside of the companys 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 wont 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 culture.

Philips Transparency Details:

• The pay range for this position in Murrysville PA is $92000 to $146000.

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.

At Philips it is not typical for an individual to be hired at or near the top end of the range for their role and compensation decisions are dependent upon the facts and circumstances of each case.

In addition other compensation such as an annual incentive bonus sales commission or long-term incentives may be offered. Employees are eligible to participate in our comprehensive Philips Total Rewards benefits program which includes a generous PTO 401k (up to 7% match) HSA (with company contribution) stock purchase plan education reimbursement and much more. Details about our benefits can be found here.

Additional Information:

• 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 Murrysville PA.
• May require travel up to 10%.

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This requisition is expected to stay active for 45 days but may close earlier if a successful candidate is selected or business necessity dictates. Interested candidates are encouraged to apply as soon as possible to ensure consideration.

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