Senior Design Quality Engineer

Job Title

Job Description

The Senior Design Quality Engineer is responsible for the entire design control process from validating design inputs to overseeing verification validation and design transfer as well as leading comprehensive process validation strategies to ensure new products meet quality and regulatory standards during production.

Your role:

• Plan and execute comprehensive process validation strategies using statistical tools to ensure seamless transition of new products to production meeting quality and regulatory standards.
• Leads the entire design control process from eliciting and validating design inputs to managing verification validation and smooth design transfer ensuring rigorous adherence to regulatory and quality standards. Leads quality improvement projects by integrating quality reliability and Post Market Surveillance (PMS) insights into all stages of the product lifecycle driving continuous enhancement of product quality and reliability.
• Drafts and upholds detailed quality engineering documents including quality plans for hardware software and systems ensuring all documentation is accurate up-to-date and compliant with regulatory requirements.
• Conducts thorough assessments of product and system designs reviews performance data and performs root cause analysis to identify and address quality deficiencies ensuring the highest standards of design excellence.
• Validates critical design inputs such as usability reliability performance manufacturability and safety ensuring alignment with both quality standards and regulatory requirements.
• Guides comprehensive risk management activities throughout the product lifecycle ensuring potential risks are accurately identified assessed and effectively mitigated to uphold product safety and quality.
• Leverages post-market performance data to assess product effectiveness in the field providing actionable feedback to manufacturing and design teams and initiating corrective actions when necessary.
• Ensures preparation for quality audits and inspections maintaining all necessary documentation and processes to demonstrate compliance with both internal and external quality standards.
• Records manages and executes CAPA processes including problem identification root cause analysis and implementation of solutions to prevent recurrence and drive continuous improvement.
• Apply continuous improvement techniques to enhance quality practices ensuring ongoing audit readiness and strict adherence to both internal and external quality standards throughout the product lifecycle.
• Builds and nurtures effective relationships with internal and external stakeholders providing expert guidance and mentorship to cross-functional teams ensuring alignment with quality standards and successful project milestones.

Youre the right fit if:

• You have a minimum of 7 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 Controls.
• You have extensive experience supporting the creation and review of all medical device documentation including- Component qualification Hardware/Firmware Design Verification Test/regression plans test protocols/reports process validation issue tracking/resolution and auditing Design History Files (DHF).
• 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.
• You have extensive experience in CAPA processes including problem identification root cause analysis implementation of solutions to prevent recurrence and drive continuous improvement.
• Youre experienced in utilizing Quality Reliability and 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 Bothell WA is $133560 to $213696.

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 Bothell WA.
• 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.