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
• Validates key design inputs like 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.
• Can Lead quality related problem solving and root cause analysis during design and manufacturing
• Uses post-market analytics and statistics to report on product quality performance in the field (provide feedback to manufacturing, suppliers or design teams) and initiates field actions when required.
• Performs independent technical assessment on product quality performance and post-market product quality analysis
• Provide leadership and oversight to ensure Quality Management System Compliance
• Be able to plan, control, and assure product and process quality in accordance with quality principles, which include planning processes, material control, acceptance sampling, and measurement systems
• Ensure the compliance requirements are met during Design review , design verification & Design validation , Design transfer
• Apply and facilitate Design for Quality & Reliability best practices (FMEAs, robust design, V&V, root cause analysis & problem solving)

You are a part of

The Philips Hospital Respiratory Care business group, supporting products including invasive and noninvasive hospital ventilators, patient interfaces, sensors, and monitoring equipment.   We believe that by understanding our customers’ problems we can ease the discomfort of ventilation by providing innovative solutions to improve the patient-ventilator experience, permit speech, and speed liberation. These technological breakthroughs allow the clinician to concentrate more on the patient and less on the device.

To succeed in this role, you’ll need a customer-first attitude and the following

• Bachelor’s Engineering degree with 12+ years of related experience or Master’s degree with 5+ years of related experience -Mechanical/ Electrical/ Electronic or Equivalent Engineering
  • Engineering Degree or equivalent experience in medical device industry
  • 5+ years’ experience with a medical device company preferably
• Can Lead quality related problem solving and root cause analysis during design and manufacturing

• Applied knowledge of appropriate global medical device or consumer product regulations, requirements, and standards (21 CFR Parts 820, ISO13485, ISO14971, MEDDEV, EU MDR, etc.)
• Experience or understanding of Software or Hardware development, Verification and Validation, Risk management, RCA, Requirements Management, Design, Usability.
  • Have an understanding of Sample Size Determination and Statistical Methods , Safety Risk Management (i.e ISO 14971) and Failure Modes and Effects Analysis (FMEA) / Fault Tree Analysis-.
  • Have understanding of a quality system and its development, documentation, and implementation with respect to domestic and international standards or requirements.
  • Have an understanding of the audit process including types of audits, planning, preparation, execution, reporting results, and follow-up.
  • Be able to develop and implement quality programs, including tracking, analyzing, reporting, and problem solving.

In return, we offer you

A path towards your most rewarding career. Philips is growing its marketing capability enterprise wide. Succeeding in this global role in a complex environment will open many doors for your long-term career, in other areas in Philips or otherwise. We also believe that we are at our best as a company when you are at yours as a person. Thus, we offer competitive health benefits, a flexible work schedule and access to local well-being focused activities. Furthermore, Philips University is available to all employees for learning and development opportunities.