Carestream
Sr. Product Safety Engineer
This job is now closed
Job Description
- Req#: 3531
- Understands and can apply current global product safety regulations pertaining to medical and information technology equipment. Reviews emerging regulations for potential impacts and proposes compliance plans
- Provides engineering support to new product commercialization teams to ensure compliance of products before market release
- Consults with existing manufacturing teams to ensure compliance of process modifications or new construction
- Maintains testing & product configuration data to demonstrate continued compliance
- Reviews & approves safety related information prepared for manufacturing, end-users and service personnel (e.g., final product testing, User Guides, marketing brochures, web site, procedures, etc.)
- Assists in the compliance planning & use of external testing services
- Reviews and prepares, as necessary, compliance reports to regulatory agencies and management
- Identifies & coordinates training to meet the needs of the engineering community
- Interfaces and participates in site inspections from certification agencies
- Participates, as needed, in the analysis & resolution of potential field related safety issues
- BS Electrical Engineering or Biomedical Engineering (advanced degree preferred) or equivalent experience
- Minimum 5 years’ experience in the design and testing of equipment and safety compliance topics
- Demonstrated experience in managing product safety compliance
- Effective written and verbal communications skills
- Ability to work independently & proven proficiency in project management and problem solving
- Working knowledge of MS Office tools (Outlook, Word, Power Point, Teams etc.) with demonstrated proficiencies in Excel
- Demonstrated experience interacting with Regulatory/Safety Testing Agencies
- Experience in Risk Management Process and Product Risk Analysis
- Knowledge about international Medical Device Regulations
- Required Training/Safety Standard Experience
- Safety compliance with medical devices
- IEC 60601-1 Family(Collateral/Particular)
- IEC 60950-1
- IEC 62368-1
- ISO 1497
Innovation that sparks imagination. Continue on to your next challenge with us.
Carestream is a worldwide provider of medical imaging systems and solutions; x-ray imaging systems for non-destructive testing; manufacturing of film and precision contract coating services for a wide range of industrial, medical, electronic and other applications—all backed by a global service and support network. Carestream’s diagnostic imaging technology systems are at work in 90 percent of hospitals worldwide.
At Carestream, we offer a global perspective and a world of opportunities for people who have the desire to make a positive impact. Join our global team of 3,000+ professionals!
Position Summary:
Carestream is hiring a Senior Product Safety Engineer to provide support across the company for product safety related issues. This position is located in Rochester, NY.
The Senior Product Safety Engineer coordinates and manages the company’s product safety compliance program ensuring that our products are safe for consumers, users, and the
environment. The Senior Product Safety Engineer is responsible for assessing potential hazards and risks associated with products, conducting safety tests, and working to mitigate or eliminate these risks through design changes or safety measures. This person will work closely with a global network of regional ECC personnel to help assure compliance at other sites as well as regulatory agencies to ensure that products meet safety standards and compliance requirements. Travel to the various Carestream sites will be required.
Position Responsibilities:
Required Skills & Education:
Desired Skills:
Work Environment:
Office, home office, labs, manufacturing
Physical Requirements:
Normal finger dexterity
Ability to use test equipment such as leakage current testers and thermal couples
Compensation of $110 - $140K
*This range reflects Carestream’s good faith estimate to pay fairly as starting wage. Offers will be tailored within the range based on the selected candidate’s experience, industry knowledge, technical and communication skills, and other factors that may prove relevant during the interview process, as well as geographic market differentials for the position.
Carestream is an Equal Opportunity Employer
Carestream is an equal opportunity organization. We recruit, employ, train, compensate, and promote without regard to race, religion, creed, color, national origin, age, gender, sexual orientation, gender identity, marital status, disability, veteran status, or any other basis protected by applicable federal, state or local law.
Applying for a job with Carestream
All applicants must complete the on-line application process. Carestream is committed to working with and providing reasonable accommodations to individuals with disabilities. If you require assistance or an accommodation because of a disability to participate in the application process, please click accommodations
Requisition ID: 3531
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