Principal Design Assurance Engineer (Sustaining)

Job Title
Principal Design Assurance Engineer (Sustaining)

Job Description

Principal Design Assurance Engineer (San Diego preferred, or other U.S. sites)

The Principal Design Assurance Engineer (sustaining) will be responsible for leading, supporting and maintaining the design lifecycle of image guided therapy consoles (both hardware and software). The successful candidate will be a confident problem solver with extensive hardware technical knowledge, able to identify potential issues and implement solutions, while ensuring that all products meet the highest quality standards. This individual will be expected to apply their knowledge of design control principles, statistics, process/systems validation, and quality engineering techniques to positively influence sustaining engineering and remediation projects. This individual shall also ensure changes to products are developed and manufactured to applicable industry standards, regulatory requirements, and customer requirements.

• Represent Design Quality Engineering on product/process project teams to ensure product changes (design, supplier, obsolescence) meet pre-defined design input requirements as well as applicable laws and standards (21 CFR 820, ISO 13485, IEC/ISO). Lead and provide guidance to cross functional teams (Engineering, R&D, Regulatory, Operations, Supplier Quality) to ensure design control requirements are being followed during design verification and validation activities.
• Lead and execute high visibility risk assessments for complex technical and process issues to ensure all potential risks are identified, assessed, documented, and appropriately addressed.
• Participate in design reviews to ensure all pre-defined requirements have been met. Lead the risk management process and on-going maintenance of the risk management file (Risk Management Plan, FMEAs, Hazard Analysis, Risk Management Report). Ability to perform risk assessments for product changes (design, supplier, obsolescence) and update of the risk documentation, as necessary.
• Lead the investigation of complex product issues (CAPAs, NCRs, Issue Impact Assessments) and recommend appropriate preventive/corrective actions. Assess complex product designs (hardware/software-based console systems) and lead/evaluate test protocols/reports to ensure testing is sufficient to meet quality objectives, applicable laws and standards and regulatory requirements. In addition, ensure the testing demonstrated the ability to meet pre-defined acceptance criteria.
• Analyze and investigate returned product (through customer complaints) to determine root cause and recommend preventive actions/measures. Monitoring/trending of product issues/complaints and initiating appropriate quality planning principles to resolve such issues. Ability to use quality tools for effective problem solving (5 Why, Pareto, Fish bone, FMEA).
• Maintain knowledge of current regulatory requirements, applicable laws, and standards as well as internal quality system requirements. Represent Philips as appropriate FDA, notified body, internal and external audits. Mentoring of junior staff that includes training, motivation, and monitoring.

• You've acquired 7+ years of relevant experience working in a regulated industry with full working knowledge of 21 CFR 820 and ISO 13485 medical device requirements. Experience with medical device hardware/software systems is required with experience leveraging software as a medical device (SaMD).
• Your skills include a strong knowledge of electrical engineering principles with respect to systems, sub-systems, and components. Ability to thoroughly understand complex hardware systems and understanding of how the system works/operates.
• You have demonstrated experience in supporting/performing failure analysis for complex electromechanical systems and/or components (including powered disposables) in order to confirm issue root cause.
• You have a bachelor's degree or higher in either Electrical Engineering (strongly preferred) or Biomedical Engineering. or equivalent combination of experience.

• You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this Office/Remote position.
• Strong interpersonal, organizational, and project management skills. Demonstrated skills in decision making/problem solving and the ability to lead project teams when roadblocks/challenges exist.
• Use of statistical analysis techniques and software for basic data interpretation (Minitab preferred). Use of various tools including microscopes, multimeters, and other inspection equipment. Proficient in relevant software programs (Microsoft Word, PowerPoint, Excel, and Project).

• Learn more about our business .
• Discover our rich and exciting history.
• Learn more about our purpose.
• Read more about our employee benefits .