Product Safety Quality Engineer

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 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.

• 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.
• Performs 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.

• Have 2+ years of experience with a Bachelor’s OR some experience with a 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.), FMEA’s, risk management related activities, Design for Quality (DFQ), and root cause analysis methods.
• Ability to perform the minimum physical, cognitive and environmental job requirements with or without accommodation for this position.
• Excellent communication skills, with an ability to influence cross‑functional stakeholders utilizing technical expertise and knowledge of risk management best practices.

The pay range for this position in Orlando, FL and Murrysville, PA is $92,000 to $146,000. The pay range for this position in Cambridge, MA is $103,000 to $163,000. The actual base pay offered may vary within the posted ranges depending on multiple factors including job‑related knowledge, skills, experience, business needs, geographical location, and internal equity. In addition, other compensation, such as an annual incentive bonus, sales commission or long‑term incentives may be offered.

Employees are eligible to participate in our comprehensive benefits program, which includes a generous PTO, 401(k) (up to 7% match), HSA (with company contribution), stock purchase plan, education reimbursement and more.

US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work‑authorized visa, now or in the future. Company relocation benefits will not be provided for this position. You must reside in or within commuting distance to posted locations. Philips is an Equal Employment and Opportunity Employer including Disability/Vets and maintains a drug‑free workplace.