Position: Product Compliance Engineer
Industry: Medical Device
Location: Washington State
A Medical Device client is looking for a Product Compliance Engineer to join their team at their Washington State facility. My client is known for their innovation and development of diagnostic equipment used by healthcare professionals to monitor and asses the electrical activity of the nervous system.
Responsibilities:
- Define, document, analyze, perform, and interpret safety/EMC tests for company products, systems, and components.
- Review existing and potential engineering projects and product designs for compliance to safety standards with the Engineering team.
- Identify functional safety/EMC issues and provide resolutions.
- Manage risk management activities for new and existing systems.
- Serve as the safety resource for all issues from incoming inspection of supplier materials to final inspection of products.
- Ensure manufacturing testing procedures are in compliance with company and regulatory requirements.
- Manage projects through agency testing, and maintain required documentation.
- Coordinate with vendors or suppliers to modify or develop testing for components or other parts.
- Manage safety audits and resolution of audit findings.
- Participate in the development of IEC60601 safety and EMC standards.
Qualifications:
- Bachelor’s degree in Engineering or related field.
- 2+ years of experience successfully obtaining EMC, EMI, ESD, or safety certifications involving medical equipment.
If you are interested in this role, please reach out to Ian Guarini (ian.guarini@dsjglobal.com) or apply in for more information!
