Sr Approvals Engineer• Responsible for educating the business on all aspects of compliance with US and international standards and regulations governing the manufacturing and selling of our products.
• Subsequently responsible for facilitating the approvals process to gain and maintain market access.
• System expert on test lab capabilities with respect to approvals testing processes and equipment. Primary goal is to assure product compliance while designs meet functional requirements and design inputs throughout the product life.
ESSENTIAL FUNCTIONS:
• Possesses and applies a broad knowledge of principles, practices, and procedures to verify product design conformance to US and international electrical and mechanical standards, regulations, and initiatives. Provide direction and support to lab personnel with respect to compliance testing, design, and sustainment of engineering teams in relation to compliance issues, and 3rd party labs with respect to our product compliance testing.
• Development and execution of test plans with design, quality, and test teams. Works with Electrical and Mechanical Test Engineers to ensure the correct test processes and procedures are followed to gain and maintain product compliance.
• Primarily responsible for any equipment, processes, accreditation, documentation, or audits associated with internal certification, preliminary compliance and compliance testing. Assists in designing and installing process sampling systems, procedures, statistical techniques, testing mechanisms, and equipment associated with compliance testing. Assists the design teams in analyzing acquired data and failures in order to provide actionable information to help improve design quality and efficiency with respect to compliance.
• Evaluates, recommends, procures and/or maintains various processes, procedures, architecture, equipment, programs, instrumentation and other technologies for continuous improvements in compliance or compliance testing.
• Acts as technical lead for design, sustainment engineering, and test team members, third party labs, or contractors as necessary. Supports all of the above during engineering work arming each group with the information necessary to drive product compliance with the applicable standards.
• As necessary, participates in audits by regulatory compliance agencies in order to provide expertise and input for any technical issues, actions, or decisions.
• Primary representative for all compliance related issues effecting new product development or existing product sustainment engineering.
• Works with minimum supervision while conferring with more senior staff on unusual matters.
• Assignments are broad in nature, requiring originality and ingenuity.
QUALIFICATIONS:
• Bachelors Degree in Electrical Engineering or related field
• GPA minimum of 3.0, strongly preferred
• Achieved a limited (learning) level of industry knowledge
• Competent with Microsoft Office (Outlook, Excel, Word, etc.)
• Demonstrated competence in product design theory and application as applied specifically to electrical hardware and architecture, microcontroller, microprocessor, wireless technologies, embedded systems but also familiarity with mechanical components and products, preferred.
• Demonstrated competence in electrical testing equipment and processes as well as an understanding and use of dynamic analytical methods/tools for analyzing electrical, software, and mechanical platforms, preferred
• General knowledge of compliance with the Code of Federal Regulations is beneficial.
• General knowledge of OrCAD Schematic Capture and PBC Layout tools is preferred
• Work within and apply the following standards in the development of our products (not limited to the below standards) is preferred:
o IEC 60601-1 (General Safety Requirements for Medical Electrical Equipment)
o IEC 60601-1-2 (EMC)
o IEC 60601-2-38 (Electrically Operated Hospital Beds)
o IEC 60529 (Ingress Protection for Enclosures)
o IEC 61000 Series (EMC Testing Techniques)
o UL 60601-1 (Medical Electrical Equipment)
o UL 746C (Polymeric Material Used In Electrical Equipment)
o UL 1069 (Hospital Signaling and Nurse Call Equipment)
o Any ISO/AAMI Related Standards
o Applicable FCC Requirements
• Must possess excellent oral and written communication skills.
• Posses an eagerness to assist internal and external customers.
• Possess attention to detail.
PHYSICAL/SAFETY REQUIREMENTS
• May involve prolonged periods of stooping, kneeling, crouching, bending, sitting, standing, and/or crawling as appropriate.
• May be required to move materials up to 50 pounds, reach, push, or pull in order to accomplish job accountabilities.
• Coordination of eye, hand, and/or foot movement with an ability to grasp by hand and meet cognitive demands to include visual and auditory discrimination/memory, reading ability, and memory retention ability.
• Requires use of safety glasses in designated areas.
• Closed-toe/heel shoes must be worn on the production floor; safety shoes are recommended.
Qualifications/Work Experience
• Work within and apply the following standards in the development of our products (not limited to the below standards) is preferred:
o IEC 60601-1 (General Safety Requirements for Medical Electrical Equipment)
o IEC 60601-1-2 (EMC)
o IEC 60601-2-38 (Electrically Operated Hospital Beds)
o IEC 60529 (Ingress Protection for Enclosures)
o IEC 61000 Series (EMC Testing Techniques)
o UL 60601-1 (Medical Electrical Equipment)
o UL 746C (Polymeric Material Used In Electrical Equipment)
o UL 1069 (Hospital Signaling and Nurse Call Equipment)
o Any ISO/AAMI Related Standards
o Applicable FCC Requirements
Education and/or Special Training
• Bachelors Degree in Electrical Engineering or related field
• GPA minimum of 3.0, strongly preferred
• Achieved a limited (learning) level of industry knowledge
• Competent with Microsoft Office (Outlook, Excel, Word, etc.)
General knowledge of compliance with the Code of Federal Regulations
•General knowledge of OrCAD Schematic Capture and PBC Layout tools is preferred
Percent Travel Required
10%
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