Product Safety & Regulatory Engineer

at Thermo Fisher Scientific
Location Madison, Wisconsin
Date Posted November 4, 2020
Category Bioscience
Job Type Full-time
Address 525 Verona Rd

Description

When you join us at Thermo Fisher Scientific, you’ll be part of a smart, driven team that shares your passion for exploration and discovery. With revenues of $22 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world.

Location/Division Specific Information
The role supports our Material and Structural analysis division supporting the products safety of our Electronic Microscopes and Molecular and Elemental spectroscopy solutions.

How will you make an impact?
The Product Safety Compliance engineer is responsible to identify, communicate and verify that all Product safety requirements are implemented by design in new Electron Microscopy and Spectroscopy products and modules. He/she will be based in Hillsboro or Madison, WI and be part of the global product safety compliance / regulatory team reporting into the global manager of the team.

How will you get here?

Education:

  • A bachelor’s degree in engineering is required, or a combination of education and experience that demonstrate the required skills

Education:

  • ~5-10 years of relevant working experience in Product safety and regulatory compliance.
  • Proven experience to judge engineering solutions and their impact in product safety, mechanics, EMC, electrical & electronic, chemical, X-ray, laser, pressure vessel and publications.
  • A demonstrated working knowledge of CE directives, e.g., Machinery directive, EMC directive, EURATOM Ionizing Radiation Directive and Pressure Equipment Directive. Thorough understanding of the IEC 61010-1 standard with proven expertise in evaluating and testing products against the specified design requirements. And preferred working knowledge of international standards like SEMI S2, SEMI S8 and NFPA79.
  • Experience in working together with safety and regulatory test labs (NoBo’s/NRTL labs), reviewing test results, approving test reports and addressing compliance issues.
  • Experience working in high-tech environment, and specifically capital equipment is preferred
  • Capable to translate the safety and regulatory requirements into design requirements for R&D engineers which don’t have the product safety and regulatory knowledge
  • Excellent interpersonal and communications skills with the ability to interact effectively with others, which includes senior and middle management levels.
  • Ability to work in a high-matrixed organization: To synthesize various inputs and concerns, negotiate, and find paths forward that lead to results.
  • Able to work independently, be a self-starter
  • Qualified as Radiation safety officer is preferred
  • Willing to travel up to 25% time

Knowledge, Skills, Abilities

  • Global Communication across various cultures
  • Flexibility
  • Ability to multitask, handling multiple projects
  • Good verbal and written communication skills
  • Influence & Persuasion
  • Unwavering quality, regulatory /EHS ethics
  • Bench level experience in R&D, Process Development or Manufacturing
  • Relationship Management
  • Project Management
  • Systematic Problem solving
  • Teamwork

Click here to learn more & apply today!