Design Quality Engineer - Medical Devices

Philips; Chakan; On-site; INR 900,000 - 1,400,000; Full time

Job summary

Philips in Maharashtra, India, is seeking a Design Quality Engineer to support the quality, reliability and safety of medical devices across their lifecycle. You will lead design quality activities, oversee FMEAs, risk management, and product quality plans, interfacing with regulatory affairs and cross-functional teams to ensure patient safety and regulatory compliance.

The role requires 5+ years in healthcare/medical device quality, a relevant engineering degree, and strong English

Qualifications

• 5+ years in healthcare/medical device quality engineering.
• Experience validating design inputs for usability, reliability and safety.
• Bachelor's or Master's in relevant engineering/science field.
• ASQ CQE or CQM preferred.

Responsibilities

• Establish quality and reliability strategy for the product scope.
• Lead Product Quality Plan activities to meet targets.
• Review reliability plans and FMEAs; ensure design transfer to manufacturing.
• Drive RCA and corrective actions for post-market issues.

Skills

Quality engineering

Medical device industry

Regulatory compliance

Design for Quality

Education

Bachelor's or Master's in Mechanical/Electronics/Science

ASQ CQE or CQM preferred

Job description

Design Quality Engineer

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

Key Responsibilities

• 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 KAR's Ensures that the Voice of the Patient/Consumer is adequately represented in the project team ensuring patient/consumer safety and quality in decision making, e.g. setting of unambiguous appropriate customer/patient-focused targets (reliability, usability, availability, serviceability, manufacturability)
• Is single point of contact in project teams for end-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 manages the wholistic patient/consumer safety, quality and reliability strategy and approach, overseeing execution and quality of results, 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 all phases of the project, 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, e.g. Design for Reliability, Design for Six Sigma, RCA, etc, to support the quality objectives
• Ensures patient/consumer safety & quality in Design Reviews, FMEA and Safety Risk Management, including CTS/CTQ attribute usage, and Verification & Validation with appropriate statistical confidence and reliability
• Assesses patient/consumer safety & quality performance throughout all phases of the project and post-launch product quality analysis during the monitoring phase, reporting (with sufficient objectiveness and coverage) at the project gates
• Feeds back patient/consumer safety & quality related 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

Requirements

• 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: Bachelor's Degree/Master's 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 company’s facilities. Field roles are most effectively done outside of the company’s main facilities, generally at the customers’ or suppliers’ locations. Indicate if this role is an office/field/onsite 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 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 of impact with care here .

Experience Level Mid Level