Product Safety Quality Engineer

Philips International; Northern (KY); Hybrid; USD 92,000 - 163,000; Full time

Benefits offered by this job

PTO

401k

HSA

Stock purchase plan

Education reimbursement

Job summary

Philips is seeking a Product Safety Quality Engineer for hospital patient monitoring devices. The role emphasizes safety and compliance, with independent assessment of complex designs using FMEA and FTA to uncover hazards and improve reliability.

You will document risks, apply ISO 13485/14971 and IEC 62304/82304 practices, and collaborate with cross-functional teams to ensure thorough safety coverage. Office-based with required in-person presence.

Qualifications

• 2+ years with Bachelor’s or 5+ years with Master’s in DFMEA, product quality, and risk management in medical devices.
• Strong knowledge of ISO 13485, 14971; IEC 62304, 82304, and risk management methods.

Responsibilities

• Perform risk assessments using FMEA and FTA on product designs.
• Identify hazards, document risks, and ensure safety/reliability through systematic analyses.

Skills

FMEA

Risk management

DFMEA

Product quality

Education

Bachelor's degree in a relevant field

Master's degree in related field (DFMEA, risk mgmt)

Job description

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, 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.

Qualifications

• You’ve acquired 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.
• Your skills include a 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.

Responsibilities

• You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position.
• You’re an excellent communicator, with an ability to influence cross-functional stakeholders utilizing your technical expertise and knowledge of risk management best practices.

Work Arrangements and Location

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. This is an office-based role.

Locations and Pay

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.

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.

Eligibility

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. For this position, you must reside in or within commuting distance to posted locations.

Equal Employment Opportunity

Philips is an Equal Employment and Opportunity Employer including Disability/Vets and maintains a drug-free workplace. At Philips, we believe that every human matters. As a global health-tech leader, we focus on improving people’s health and wellbeing through meaningful innovation. The people who work here share our passion and are motivated to bring this purpose to life. For more than 130 years, we have been creating technologies and innovations that improve people's lives and support healthcare practitioners. Headquartered in the Netherlands and operating in more than 100 countries globally, we focus our advanced technology and deep clinical and consumer insights on Precision Diagnosis, Image Guided Therapy, Enterprise Informatics, Monitoring/ Connected Care, Sleep & Respiratory Care and Personal Health. Together, we deliver better care for more people because we believe that every human matters. That's why we're taking steps to create an environment where we acknowledge and embrace our differences and uniqueness and listen to and value each other's views. When people feel cared for and listened to, they bring their best qualities to work, leading to better collaboration, communication, innovation and success. It is the policy of Philips to provide equal employment and advancement opportunities to all qualified employees and applicants for employment without regard to race, color, religion, sex, pregnancy/childbirth or related medical conditions, age, ethnic or national origin, sexual orientation, gender identity or expression, physical or mental disability, genetic information, citizenship status, veteran or military status, marital or domestic partner status or any other characteristic protected by law. As an equal opportunity employer, Philips is committed to fostering a culture where all are treated with respect and professionalism. To ensure reasonable accommodations for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veterans' Readjustment Act of 1974 and Title I of the Americans with Disabilities Act of 1990, applicants that require accommodation in the job application process may contact 888-367-7223, option 5, for assistance.