As Compliance Engineer:
- Coordination and management of standards compliance activities for assigned programs, working with cross-functional product development partners to identify requirements, develop and execute compliance plans, coordinate testing activities, review compliance testing results and partner with certification agencies to certify products.
- Partner with design engineers (Hardware, Mechanical, Software) to develop product requirements to comply with standards and regulations for intended use markets, develop Compliance Plans, participate in design and development activities and partner to resolve product certification, compliance and safety issues.
- Consult with program teams on product certification strategy and compliance issues where needed
- Facilitate and coordinate input from multiple cross-functional partners including Regulatory team, program management, R&D teams, manufacturing sites and service locations to develop comprehensive product certification and compliance strategies, and ensure that Baxter Healthcare solutions comply with product certification requirements in the intended use markets
- Keep abreast of changes to product standards and regulations affecting medical products.
- Ensure that all compliance test equipment complies with the test requirements specified in compliance standards.
- Schedule compliance testing for Baxter Healthcare products at onsite test facility and at external test laboratories. Manage product test and certification projects with onsite and external test laboratories.
- Prepare standards test reports and other documentation in accordance with applicable regulations.
- Submit documentation to regulatory authorities as required to obtain product certifications for different global regions (e.g. US, Canada, Europe, Korea, Japan, Australia/New Zealand, Latin America, Caribbean, MEA)
- Support the development System requirements and drive the cascade of the requirements to hardware and software subsystem requirements.
- Ensure appropriate traceability between requirements, interface specifications, design and verification deliverables.
- Identify compliance risks and reliability related requirements from applicable product standards (collateral and particular).
- Collaborate with cross-functional resources (e.g. hardware, clinical, human factors, etc.) involved in designing for Compliance and ensure designs provide adequate margins.
- Support sustaining teams in EMC investigation and identification of root causes.
Qualifications:
- Must possess a strong knowledge of engineering disciplines and solid knowledge of related disciplines, Electromechanical, Systems, Fluid Mechanics, Materials Sciences
- A demonstrated track record in electromechanical system development, preferably medical devices or other highly regulated products.
- Strong team player, able to meet deadlines and handle changing priorities.
- Experience in resolving complex technical problems using strong analytical skills.
- Excellent written, oral and interpersonal skills
- Must be proficient at time management and multitasking.
As Compliance Engineer:
- Knowledge of medical device requirements for Global (US, Canada, Europe, Korea, Japan, Australia/New Zealand, Latin America, Caribbean, MEA)
- Knowledge and Hands on experience on all EMI/EMC standards/tests and knowledge of EMC regulations and certification procedures applicable to Medical Devices globally including testing documentation, certification requirements and procedures (i.e. IEC/EN60601, CISPR 11, FCC, EU, IC etc.).
- Hands on experience on Safety standards (IEC 60601 series) including collateral and particular standards
- In depth knowledge on wireless regulations and standards (ETSI series, FCC, IC, RED (Radio equipment directives) for medical products
- Familiarity with regulatory requirements of FDA and EU MDR.
- Ability to perform diagnostics and correct EMC failures in conjunction with design engineers
- Strong electronics background is essential
- Strong experience in Requirements Management, Configuration Management, Defect Tracking and Traceability
- Experience with EMC design tools, automated EMC testing tools, electronic test equipment (scopes, logic analyzers)
- Knowledge of FDA's guidance on design controls and software validation, as well as ANSI/IEEE standards for EMC engineering
- Demonstrated experience interfacing with regulatory agencies, conformity assessment bodies (UL, Intertek, CSA, etc.) and standards development organizations (IEC, ISO, NEMA, NFPA, ETSI, etc.).
Education and/or Experience:
- Graduate or Postgraduate in Biomedical, Mechanical, Electrical, Electronics or related Engineering. An advanced technical degree is desired.
- 8-10 years of relevant technical experience in defining systems and requirements for medical products.
