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Danaher Corporation Product Compliance Engineer (Safety) in Toronto, Ontario

For over 50 years, SCIEX has been developing groundbreaking technologies and solutions in mass spectrometry and capillary electrophoresis. Our products enable our customers to quickly respond to environmental hazards, better understand biomarkers relevant to disease, improve patient care in the clinic, bring relevant drugs to market faster and keep food healthier and safer. At SCIEX, you’ll find a rewarding role that amplifies your impact on the world and helps you realize life’s potential.

SCIEX is proud to work alongside a community of nine fellow Danaher Life Sciences companies. Together, we’re pioneering the future of science and medicine, developing products that enable researchers in the fight to save lives.

Are you outstanding, committed, and talented? Know your worth because you have greatness in you. What you find at SCIEX — and within yourself — might just change the world!

The Product Compliance Engineer ensures SCIEX’s alignment based on corporate policy, international regulations, and standards. This role is the Lead on project teams in order to ensure that the requirements are clearly communicated, understood, and satisfied.

In this role, you will have the opportunity to:

  • Generate data and reports relating to compliance for use in reporting SCIEX status to countries and regions. Conduct all interactions with regulatory agencies to achieve and maintain compliance and obtain certifications specified for the product, including but not limited to CSA, UL, FCC, and FDA CDRH (for laser safety).

  • Generate and update reports for new or existing products pertaining to product safety, electromagnetic compatibility, packaging and environmental compliance.

  • Conduct product safety related investigations on field reported problems or incidents. Evaluate or direct evaluation of OEM products and test procedures per global regulatory requirements.

  • Lead and support the CSA Category Program for Certification (CPC) as needed. Build Standard Operating Procedures on an as-needed basis.

  • Develop, modify, verify and validate of test methods as needed.

Key Requirements:

  • Bachelors degree in Electrical, Mechanical, Mechatronics Engineering or closely related field.

  • Prefer 5+ years of product safety and EMI/EMC test experience in a corporate environment with R&D, engineering and manufacturing operations.

  • Knowledge of product Regulatory Standards (i.e. CSA, UL, IEC, etc.) and their application to products, including EMI/EMC and safety requirements and tests.

  • Knowledge of global product regulatory including European, North American, Chinese, Korean, Australian, and other countries (i.e. CSA mark, CE mark, FCC, FDA CDRH, RoHS, WEEE, etc.).

  • Familiarity with analytical instruments or medical device development is an asset.

Key Attributes:

  • Master’s Degree

  • Professional Certification (PEO or OACETT)

  • Knowledge of European and North American regulatory requirements (CE Marking, SCC, CEC, FCC, NEC, OSHA)

  • Knowledge of Environmental Compliance regulations (RoHS, REACH, Prop 65, WEEE, etc.) is an asset

  • Knowledge of test equipment selection, functionality, operation, and calibration requirements

  • Familiarity with ISO 9001, ISO 13485 and ISO IEC 17025 quality system elements and operation

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#bestteamwins

When you join us, you’ll also be joining Danaher’s global organization, where 80,000 people wake up every day determined to help our customers win. As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System (https://www.danaher.com/how-we-work/danaher-business-system) tools and the stability of a tested organization.At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.If you’ve ever wondered what’s within you, there’s no better time to find out.

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