Position Summary:
The Product Compliance / Safety Engineer is responsible for obtaining agency certifications for new and updated Class I and II medical devices. As a Product Compliance / Safety Engineer, you will manage safety / EMC testing , contribute to regulatory submissions, and collaborate with our experienced engineering team to design Class I and II medical devices. This vital role ensures Cadwell products meet applicable standards and regulatory requirements for successful worldwide registrations.
Key Duties / Responsibilities:
- Define, document, analyze, perform, and interpret safety/EMC tests for Cadwell products, systems, and components
- Partner with engineers to review existing or potential engineering projects and product designs for compliance to safety standards; Advise on required component ratings
- Identify functional safety/EMC issues and suggest resolutions; Coordinate necessary changes with engineers
- Manage risk management activities for new and existing Cadwell 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
- Perform other duties as requested, directed, or assigned
Education / Experience:
- Bachelor’s degree in Engineering or related field required; experience accepted in lieu of degree
- 5 years of experience successfully obtaining EMC, EMI, ESD, or safety certifications involving medical equipment required
Job Knowledge / Requirements:
- Experience with relevant UL, CSA, FCC, IEC and EN standards, including usability and risk management
- Experience with IEC60601 standards
- Experience with FDA and MDR requirements for medical devices and international regulatory approvals
- Experience analyzing analog and digital electronics for compliance, including power supplies, isolation circuitry, and embedded microprocessors/controllers desired
- Ability to interpret engineering drawings and electrical schematics, with basic understanding of the manufacture of electrical systems
- Experience interacting with external auditors; experience explaining and defending practices on safety, and EMC to external auditors and to regulatory agencies
- Read and understand complex regulations and requirements, and develop pragmatic compliance solutions
- Knowledge of standard concepts, practices, and procedures within the medical devices field
- Strong analytical and logical problem-solving skills
- Competency in computer skills: MS Office and Google applications
- Strong written and oral communication skills required, including understanding, explaining, presenting and documenting complex technical processes and issues
- Interact with co-workers and customers with a professional and solutions-oriented approach
- Complete work both independently and as an effective member of the team, adapting to changing requirements, deadlines, and priorities as needed
Physical Requirements / Working Conditions:
- Positions working with Cadwell equipment generally may require some reaching, bending, stooping, squatting, crawling, kneeling, pushing, pulling, lifting and carrying up to 50 pounds, finger dexterity, repetitive motions, standing, walking, sitting, hearing, visual acuity, color vision, and 2-way written/verbal communication. More specific details may be provided as needed or requested.
- Extensive use of computer
- Domestic and international travel may be required; must be able to obtain necessary travel documents
- Work hours outside normal business hours may be required to meet business needs
Cadwell Industries, Inc. is an Equal Opportunity Employer, and as such affirms the right of every person to participate in all aspects of employment without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, age, veteran status, disability, genetic information, or any other protected characteristic. If you are interested in applying for employment and need special assistance or an accommodation to apply for a posted position, contact our Human Resources department at careers@cadwell.com.