Product Safety Quality Engineer

Philips • Orlando, MA

2d • $92,000 - $163,000 • Onsite

About The Position

Product Safety Quality Engineer, Hospital Patient Monitoring The Product Safety Quality Engineer ensures that safety and compliance documentation is thorough, accurate, and aligned with regulatory standards and internal policies, all while working independently. This role rigorously assesses complex product designs using advanced analytical tools and risk assessment methods like FMEA and FTA to uncover safety insights and address challenging reliability issues. Your role: Evaluates product designs to uncover safety concerns and potential hazards. Applies advanced risk assessment tools, including Failure Mode and Effects Analysis (FMEA) and Fault Tree Analysis (FTA), during the assessment process. Perform comprehensive reviews to ensure product safety is thoroughly addressed. Identifies and documents risks that could impact reliability and compliance. Uses systematic methodologies to analyze and mitigate potential safety issues in hospital patient monitoring products.

Requirements

• 2+ years of experience with Bachelor’s OR some experience with Master’s in areas such as DFMEA’s, product quality, and risk management analysis and documentation activities in the medical device industry; 5+ years strongly preferred.
• strong knowledge of relevant regulations and standards (ISO 13485, 14971; IEC 62304, 82304, etc.)
• strong knowledge of FMEA’s, and risk management related activities, Design for Quality (DFQ), and root cause analysis methods.
• ability to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position .
• excellent communicator, with an ability to influence cross-functional stakeholders utilizing your technical expertise and knowledge of risk management best practices.

Responsibilities

• Evaluates product designs to uncover safety concerns and potential hazards.
• Applies advanced risk assessment tools, including Failure Mode and Effects Analysis (FMEA) and Fault Tree Analysis (FTA), during the assessment process.
• Perform comprehensive reviews to ensure product safety is thoroughly addressed.
• Identifies and documents risks that could impact reliability and compliance.
• Uses systematic methodologies to analyze and mitigate potential safety issues in hospital patient monitoring products.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees