Product Compliance Engineer (Safety)
As a global leader in mass spectrometry, SCIEX delivers solutions for precision detection and quantification of molecules to help protect and advance the wellness and safety of all. Because of our 50 years of groundbreaking innovation, our customers can 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 at our Concord, Ontario, Canada site working within the Product Compliance team will support new product development and existing products to provide regulatory compliance related to Product Safety, Electromagnetic Compatibility (EMC), Packaging and restricted material (e.g. RoHS and REACH).
- Ensure SCIEX’s adherence to Product Compliance based on corporate policy, international regulations and standards.
- Generate product Compliance test and verification plans.
- Generate data and reports relating to compliance for use in reporting SCIEX status to countries and regions.
- Generate and update reports for new or existing products pertaining to product safety, electromagnetic compatibility, packaging and restricted material compliance.
- Conduct and perform Product Compliance Safety and EMC testing either in house or at an outside test agency. The hands-on testing activities represent about 25% of the time in this role.
- Support the operation of the compliance lab to ensure equipment and facilities are safe, compliant with procedures and operational.
- Create Standard Operating Procedures on an as-needed basis.
- Develop, modify, verify and validate of test methods as needed.
- Perform data analysis including test results and statements of conformity.
Education and/or Work Experience Requirements:
- Bachelors in Electrical/Mechanical/Mechatronics Engineering.
- Prefer minimum 2 years of experience in a design environment.
- Strong project management skills to estimate, report status, and deliver individual assigned tasks.
- Experience with product safety and/or EMI/EMC testing is an asset.
- Familiarity with analytical instruments or medical device development is an asset.
- Experience working in an ISO 9001/17025/13485-based quality management system environment is an asset.
- Knowledge of international regulatory standards (e.g. CSA, CEN, IEC, UL) and their application is an asset
- Professional Certification (PEO or OACETT) is an asset
- Knowledge of European and North American regulatory requirements (CE Marking, SCC, CEC, FCC, NEC, OSHA) is an asset
- Knowledge of restricted materials Compliance regulations (RoHS, REACH, Prop 65, WEEE, etc.) is an asset.
- Knowledge of test equipment selection, functionality, operation, and calibration requirements is an asset
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 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.