No more applications are being accepted for this job
Product Compliance - Kennewick, United States - Cadwell Industries, Inc.
Description
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.
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
#J-18808-Ljbffr