Systems Regulatory Compliance Engineer

Stratasys is a world leader in 3D printing!

Stratasys is leading the global shift to additive manufacturing with innovative 3D printing solutions for industries such as aerospace, automotive, consumer products and healthcare. Through smart and connected 3D printers, polymer materials, a software ecosystem, and parts on demand, Stratasys solutions deliver competitive advantages at every stage in the product value chain. The world’s leading organizations turn to Stratasys to transform product design, bring agility to manufacturing and supply chains, and improve patient care.

As a member of the Regulatory Affairs Department the Systems Regulatory Compliance Engineer (Electronics)

Will be part of the Hardware products Global Market Access team, responsible for escorting hardware design, certifying products towards global standards, verifying health and environmental regulations compliance, and testing for electromagnetic & radio compatibility.

Essential Duties and Responsibilities:

• Monitor, interact, report, and provide support to R&D, Engineering, and regional teams that inquire relating to aspects of compliance matters, enforcement actions, remedial activities, and regulatory compliance affairs.
• Lead product evaluations and tests by operating external laboratories, advisors, and subcontractors to meet relevant Safety, EMC and Environmental certifications.
• Perform product safety reviews, facilitate agency inspections, and maintain product regulatory compliance files.
• Evaluate regulatory trends and revisions while working with functional departments to react to upcoming changes without interruption to product compliance and certifications.
• Preparation of Technical files including the creation of a Critical Component List

Essential Education, Skills, and Abilities

• Electricity / Electronics / Electro-mechanics Engineering degree
• 5+ years of prior experience at a multidisciplinary / Medical company as a regulation compliance engineer.
• CE marking experience with a deep understanding at least of one: Machinery, Low Voltage, Radio, and EMC directives
• Deep understanding of one of the safety standards: IEC 62368-1, IEC 60950-1, IEC 60204-1, IEC 61010-1
• Extensive knowhow of USA/Canada regulations: FCC, NRTL listing, UL standards, electrical codes of NFPA
• Experience with safety risk assessment for complex systems, signal integrity, and system design for compliance
• Strong written and verbal English
• Ability to develop and maintain effective working relationships on a multi-level basis
• Ability to present technical information and effectively communicate across all levels of the organization
• External Focus: Understanding customer needs, industry trends, and the competitive landscape of the industry.

Physical/Environmental Requirements:

• Work in an office environment, possible visits in a factory environment
• Travelling – up to 10%

What​ ​you​ ​will​ ​be​ ​part​ ​of:

• Company Overview - https://www.stratasys.com/en/about-us/history/
• Our Culture and Values - https://www.stratasys.com/en/about-us/culture/
• Our Sustainability “3D Printing a Better Tomorrow” - https://www.stratasys.com/en/about-us/sustainability/
• Our Locations - https://www.stratasys.com/en/contact-us/office-locations/
• Check out our Video - https://www.youtube.com/watch?v=6wmDfmt2bNI