Senior Product Compliance Engineer
Core
Provide compliance leadership and project management to ensure EMC, safety, and RF compliance throughout product development and lifecycle processes.
Role type
Senior Product Compliance Engineer
Builds
Medical/scientific products
Domain
Medical devices / Regulatory compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
EMC compliance, RF compliance, product safety standards (IEC, UL, CSA), regulatory certification management, project planning, stakeholder engagement, risk identification, third-party audit coordination
Preferred skills
PMP certification
Technologies
FCC, IEC, UL, CSA
Responsibilities
Partner with Engineering and Operations to deliver best-in-class products; Interpret regulatory/product compliance requirements and provide input to NPD, Sales/Product Management, and Factory on product additive changes; Monitor and analyze changes in regulations and standards for U.S., Canada, and EU that may impact the organization's product compliance programs; Develop and implement project planning and execution while proactively engaging internal and external stakeholders; Oversee the coordination of EMC and Safety evaluation with Factory, Engineering, and Third-party testing partners; Identify compliance related risks, effectively communicate the threat and suggest best means for avoiding or reducing the risk; Obtain and maintain product regulatory certifications required to support commercialization of products; Provide compliance direction and take the lead on regulatory input during the product design process; Plan and support third-party audits and internal audits; Engage with NRTLs to drive compliance programs
Seniority
Senior, hands-on IC
