Senior Product Compliance Engineer

ABOUT ADVANCED ENERGY                    

Advanced Energy (Nasdaq: AEIS) is a global leader in the design and manufacturing of highly engineered, precision power conversion, measurement and control solutions for mission-critical applications and processes. AE’s power solutions enable customer innovation in complex applications for a wide range of industries including semiconductor equipment, industrial, manufacturing, telecommunications, data center computing and healthcare. With engineering know-how and responsive service and support around the globe, the company builds collaborative partnerships to meet technology advances, propel growth for its customers and innovate the future of power. Advanced Energy has devoted four decades to perfecting power for its global customers and is headquartered in Denver, Colorado.

 

POSITION SUMMARY:                                  

As a Senior Product Safety & Compliance Engineer, you will be responsible for development and execution of complex test programs to ensure compliance of medical products to the provisions of U.S., Canadian and other international product safety standards (e.g. IEC/ANSI AAMI / CSA 60601-1 and its Collateral and Particular standards).

 

RESPONSIBILITIES:

• Development of test plans to ensure certification of New Product Development
• Direct interaction with Nationally Recognized Test Labs (NRTL)
• Provide direction and support to lab personnel with respect to compliance testing and design
• Support engineering teams in relation to compliance issues, and 3rd party labs with respect to our product compliance testing
• Continuous improvement (e.g. reduce compliance cycle time)
• Review emerging regulations and changing standards for potential impact to business. Propose compliance plans to meet changing requirements
• To develop, maintain and monitor the necessary processes and documentation required to maintain compliance to NRTL level standards
• Devise new processes, or refine existing ones, to optimize the compliance process and reduce test time
• To act as a point of contact for Conformity Assessment processes during auditing of laboratories by external & Internal parties
• To act as a liaison and assist with Internal & External Audits with NRTL
• Act as liaison with certification agencies and engineering teams to assure accurate and cost-effective test strategies are implemented in a timely manner and documented in accordance with applicable global standards
• Assist the manufacturing team to maintain proper testing & product configuration data to support continued compliance
• Mentoring of junior staff

 

WORK ENVIRONMENT:

• Typically works in a professional lab environment. Occasional travel to domestic and international support offices, design centers, manufacturing locations, and customers is expected

 

QUALIFICATIONS:

• Proven ability to methodically solve multi-functional, technical issues completely in a timely manner
  • Ability to collaborate with cross-functional project teams to reach problem resolution
  • Ability to solve complex technical and interpersonal problems independently
  • Experience with influencing and negotiating complex situations
• Wide-ranging understanding of product offering, and customer applications
• Strong communication skills with an ability to interface with customers, influence design teams, and institutionalize an understanding of safety compliance goals
  • Excellent verbal and written communication and interpersonal skills
• Ability to manage multiple projects at one time
• Proficiency in the use of basic electrical laboratory tools such as multimeters, oscilloscope, power supplies, Hi-pot
• Leadership capability – motivates team to achieve goals
• Ability to train and mentor team members

 

EXPERIENCE:                                              

Essential:

• Greater than 5 years in testing high-tech product development and/or manufacturing test environment
• Experience with successfully managing individual engineering projects
• Experience with UL/IEC/CSA safety standards

 

Desirable:

• Experience with IEC 60601-1, IEC 62368-1

 

EDUCATION:                                                                                    

Essential:

• Bachelors Degree in an Electrical / Electronics Engineering or related field

 

Desirable:

• Advanced Degree in a relevant Engineering discipline
• Problem-solving methodology

 

COMPENSATION:                            

As required by multiple state pay transparency laws, A