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Global Compliance Engineer
Global Compliance Engineer - Remote Europe (m / f / d)
Hamburg PKI, Milan, Seer Green, Stockholm, Stockholm, Turku
We are seeking an experienced Compliance Engineer to drive our current instrumentation technology to the edge of science.
The individual will become a key member of a prestigious group of senior researchers, partners and collaborators.
The position reports into PerkinElmer’s R&D organization comprised of more than 800 resources located on 3 continents. This position is remote but travel will be required to the European R&D sites in Hamburg, Germany;
Seer Green, UK; Milan, Italy; or Turku, Finland
Basic Qualifications :
Bachelor's Degree in electrical or mechanical engineering preferred, but equivalent relevant experience also considered
10 years of recent engineering experience in a high technology environment.
Provide compliance subject matter expertise to research and design teams for New Product Initiatives and manufacturing engineering teams for existing legacy instruments
Use technical knowledge and significant problem-solving ability to help determine the most effective solution for complex problems spanning multiple technical disciplines.
Work in conjunction with scientists and other engineers to prove out designs.
Coordinate resolution of technical issues with members of cross functional team.
Develop measures to support initiatives and strategies.
Provides technical insight to analyze risks and opportunities and adjust plans to minimize risk and maximize opportunity.
Engineer Technical Requirements (Compliance Engineer)
Role requires broad knowledge and application of worldwide regulatory compliance laws, directives and industry specific regulations pertaining to Product Safety, Electromagnetic Compatibility, Material compliance regulations (e.g. RoHS, REACH, Conflict Minerals)
Familiarity with requirements for EU CE safety self- declaration including maintenance of safety files and support documentation for EU Declarations of Conformity
Experience with Medical, IVD or Lab and Measurement Equipment preferred
Act as liaison with Product Development teams and contract, Agency laboratories
Participate on New Product Development design reviews to provide insight and advice on design choices as they pertain to regulatory compliance standards
Maintain 3rd party Agency files for safety testing through audits, file changes and inspection payments
Possess skills to utilize industry standard CAD packages (e.g. Solid Works, Altium) to evaluate hardware compliance to certification requirements.
Create EMC test plans and maintain EMC files and support documentation for Korean RRA, Australian ACMA, FCC and CE self-declaration.
Possess a thorough understanding of the RoHS, and REACH regulations, sound engineering knowledge of materials and an appreciation of the design process.
Knowledge of manufacturing and assembly processes to help develop designs which are compliant to regulatory requirements, cost-effective and reliable.
Ability to evaluate and troubleshoot with standard test equipment (e.g., oscilloscopes, DVMs) and simulation software packages.
Possesses a strong knowledge of EMI-EMC management techniques to pass standardized testing of electronic equipment.
Ability to use standard documentation tools to create / communicate design and test specifications / results (e.g., Word, Excel, PowerPoint, Visio)
Demonstrated ability to succeed in a fast-paced environment while working on multiple projects with constantly changing priorities and deadlines.
Excellent written, verbal, and interpersonal skills.