Shire Jobs

Sr. Hardware Compliance Engineer

Location:

Eden Prairie, MN, US

Job ID: 53972

Category: Product & Engineering

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.

The Sr. Hardware Compliance Engineer will be part of the Hardware Regulatory Compliance Team, responsible for surveillance and compliance management of Stratasys’ wide multidisciplinary systems portfolio.

This position will be accountable for Stratasys products safety, electromagnetic compatibility and environmental compliance with global standards. Additionally, develop local workflows and protocols, provide tactical directions to local R&D teams and manage the administration of product compliance.

What you will be doing:

• Lead product evaluations and tests by external laboratories, advisors, and subcontractors to meet relevant Safety, EMC, and Environmental certifications

• Generate necessary documentation to support certifications and submit to the certifying laboratory/organization, maintain agency files for factory/product inspections

• Prepare technical files, including the creation of a Critical Component List

• Perform product safety reviews, facilitate agency inspections, and maintain product regulatory compliance files

• Assess local and regional compliance requirements and implement programs and systems to ensure compliance

• Monitor, report, and support R&D, engineering, and regional teams with regards to compliance, enforcement, remediation, and regulatory compliance affairs

• Maintain knowledge base of regulatory trends and revisions. Work with functional departments to anticipate changes and mitigate interruptions to product certifications

• Gather strategic intelligence on developing areas of product regulations, advise management, and ensure the implementation of required compliance actions

• Follow all company safety policies and procedures

• Attend all required company training

• Demonstrate commitments to Stratasys Behaviors by leading, acting, and modeling these values

• Other responsibilities as assigned by the department or manager

Must have for this role:

• 5+ years of prior experience

• CE marking experience with a deep understanding of at least of one: Machinery, Low Voltage and EMC directives

• Change agent with energy, passion, and enthusiasm to drive change

• Clear thinker: Simplifying strategy into specific actions with clear accountability, making decisions with speed & accuracy

• 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

• Ability to work in a multi-tasking environment with a variable priority setting

Nice to have for this role:

• EHS certifications

• Deep understanding of safety standards: IEC 62368-1, IEC 60204-1, IEC 61010-1, UL 508

• Extensive knowledge of USA/Canada regulations: FCC, NRTL listing, UL standards, NFPA 70, NFPA 79

• Experience with safety risk assessment according to ISO 12100

• Understanding customer needs, industry trends, and the competitive landscape in the industry

Travel required: 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

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Stratasys will provide reasonable accommodations for qualified individuals with disabilities. In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire.

Stratasys is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to their protected Veteran or disabled status and will not be discriminated against for their race, color, religion, sex, age, disability, military status, or national origin or any other characteristic protected under federal, state, or applicable local law. Please view Equal Employment Opportunity Posters provided by OFCCP here .