Systems Design Quality Engineer

Job Title

Job Description

Job Title:

• Systems Design Quality Engineer

You Role:

• While positioned within the Business Unit MR reporting to the Segment OEM & Coils DQE Leader you will support the Quality Reliability and Safety of Medical Devices though all lifecycle phases of the medical device.
• You will contribute to achieve quality objectives as they relate to: Customer Experience Complaint Rate and First Past Yield.
• You will work in an independent Quality & Regulatory organization with key stakeholders during various stages of the design development and maintenance of the medical device.
• Representing Design Quality during the execution of new development programs and sustaining activities and interfacing with regulatory affairs
• Independent oversight of product performance as this relates to Product Quality Safety and Reliability
• During (early) Development and Lifecycle Maintenance: Participate in establishing the quality and reliability strategy specific to the product(s) in scope. Involved in quality target setting in Project Charter
• Act as a product quality lead by defining the activities in the Product Quality Plan to meet product quality targets
• Contribute to the execution and delivery of results specific to product quality: Review reliability plans review key quality related requirements ensure a proper transfer of design specifications to manufacturing and supply chain and service perform assessment on the design/architecture on suitability for the quality criteria and review key product related deliverables (Reliability Reports Reliability modelling for predictive analysis FMEAs Change Point Analysis etc.)
• Apply and facilitate Design for Quality & Reliability best practices (FMEAs robust design V&V root cause analysis & problem solving)
• Regularly go through the history of quality issues (leverage data of post-market analysis like Complaints Quality Notifications DeFOA Defect) and drive improvement through proposals
• Support and lead quality related problem solving and root cause analysis as they relate to design and development and define and establish best practices

Your KARs

• Ensures that theVoice of the Patient/Consumeris adequately represented in the projectteam ensuring patient/consumer safety and quality in decision making e.g. setting of unambiguous appropriatecustomer/patient-focused targets(reliability usability availability serviceabilitymanufacturability)
• Is single point ofcontact in project teams forend-to-end design quality collaborating with multiple stakeholders within and outside of quality function responsible to provide direction on design quality-related matters where needed
• In partnership with other functions defines and managesthe wholistic patient/consumer safety quality and reliability strategy and approach overseeing execution and quality ofresults driving to sufficient confidence in the product/service prior to release to market
• Is responsible for appropriate and actionable quality plans (as part of Project Management Plan and/or separate) that include allphases of theproject and provides effective insight and oversight of the execution of the Quality Plan(s) Risk Management activities in accordance with QMS processes
• In partnership with other functions is responsible for delivery of patient/consumer safety quality and compliance in key design input traceable to key design output in accordance with applicable QMS processes
• Supports and drives the use of focused methodologies for Reliability Design for Six Sigma RCA etc to support the quality objectives.
• Ensures patient/consumer safety & quality in Design ReviewsFMEA and Safety RiskManagement including CTS/CTQattribute usage and Verification & Validation with appropriatestatistical confidence and reliability.
• Assesses patient/consumer safety & quality performance throughout all phases of the project and post-launch product qualityanalysis during the monitoringphase reporting (with sufficient objectiveness and coverage) at the projectgates.
• Feeds backpatient/consumer safety & qualityrelated post-market data in applicable product development & maintenance processes.
• Supports proper root cause investigation of patient/consumer safety and quality-related issues in a cross-functional approach driving corrective actions to prevent recurrence

Youre the right fit if:

• Experience: 5 years of industry experience must have experience in Healthcare/Medical device industry.
• Skills: Validates key design inputs like usability reliability performance supportability manufacturability localizability safety security privacy serviceability sustainability and costs. Applied IA knowledge is a pre.
• Education: Bachelors Degree/Masters Degree in Mechanical Engineering Electronics Engineering Science or equivalent.
• Certifications: ASQ CQE or CQM preferred. 13485 auditor preferred. High-level English language proficiency including strong writing skills.

How we work together:

• We believe that we are better together than apart. 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.
• Indicate if this role is an office/field/onsite role.

How we work together
We believe that we are better together than apart. 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.
Indicate if this role is an office/field/onsite role.
About Philips
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If youre interested in this role and have many but not all of the experiences needed we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our culture of impact with care here.