Chelmsford, United States
about 3 years ago
Principal Compliance Engineer
Principal Compliance Engineers are responsible for leading and overseeing R&D efforts to ensure company products comply with all currently applicable domestic and international safety/performance standards.
Engineers are responsible for:
- Identifying all safety/performance standards currently applicable to our medical devices;
- Maintaining the library of currently applicable standards documents;
- Interpreting those standards and determining the requirements they place on each product design;
- Working directly with product development teams to ensure that applicable standards requirements are understood and effectively addressed in each product's design and development process;
- Developing uniform testing plans and methodologies for verifying device compliance and documentation that facilitates standards agency review;
- Conducting/overseeing product testing against applicable standards requirements and developing/maintaining formal reports to document compliance;
- Identifying new standards or standards changes that will impact the design of existing products and communicating those requirements throughout R&D;
- Championing the modification of existing products to ensure their continuing compliance with current and soon to become effective standards;
- Managing the interface between R&D and outside compliance test/certification agencies.
- Contributing to the identification, analysis and management of risks associated with new products under development.
- Works directly with product development teams to identify applicable standards, document requirements they impose on new and existing products, develop and execute design for compliance plans. Evaluate the compliance of proposed new or modified designs and manage the compliance testing process inside company and with 3rd party certification labs.
- acts as primary liaison between company and 3rd party testing/certification organizations to notify 3rd parties about product changes affecting standards compliance, arrange product testing or other efforts needed to maintain certification, review 3rd party test reports for continuing accuracy, notify development teams of compliance failures requiring remediation and maintain up¬ to-date copies of all internal and 3rd party standards compliance and certification reports.
- Working knowledge of domestic and international regulations and standards applicable to medical electronic devices
- Significant experience performing hand-on compliance testing of medical devices
- Significant experience directly interfacing with standards agencies
Required/ Preferred Education and Experience:
- Bachelor of Science in Electrical Engineering or equivalent.
- 10+ years Compliance Engineering experience
- 5+ years' experience in domestic and international compliance of electronic medical devices