Compliance Engineer

Description

• Overall responsibility for ensuring that products are developed and tested in compliance with all applicable agency requirements.
• Understand medical device safety standards (IEC/UL/ES ) and regulatory requirements, and be capable of identifying those that are applicable for each unique project.
• Provide Engineering support to Regulatory Affairs to facilitate international product registration.
• Familiarity with the construction / architecture of product Technical Files, DHF, DMR, and DHR.
• Interface with Safety Agencies (ETL, UL, CSA, etc.) to coordinate RFQs and work package(s) and providing technical guidance / support during product certification.
• Provide Support TO RA / QA teams as Engineering Team liaison during FDA, Certification Agency, and ISO audits.
• Address agency non -compliance issues / audit findings. Owning and Driving closure of the findings.
• Familiar with CAPA Process and execution.
• Very knowledgeable with execution of Risk Management Processes, ISO 14971:2007, and associated tools.
• Compiles, maintains and updates CE tech files including but not limited to PMS reports, Risks, Essentials Checklists and ensuring they remain compliant
• Design for EMC and Safety Compliance to Domestic and International Agency requirements.
• Acts as objective evidence/independent reviewer and supports/conducts simulated design validation and R&D verification activities.

• BS in Electrical or Mechanical Engineering or Technical field
• Minimum 5 years experience in medical device design.
• Minimum 5 years Product Safety Certification experience is preferred.
• Solid background in engineering product development and design controls.
• Strong background in Design Control / DFM / GMP/ FDA / ISO9001/ ISO14971
• Knowledge of European directives and standards
• Experience composing memorandums to the FDA