Sr Eng, Codes and Standards

Role Overview

Systems Engineering Responsibilities

• Coordinate product systems architecture and systems-level design, including subsystem and interface specifications.
• Perform systems-engineering activities throughout new product development and post-market surveillance.
• Gather, assess, decompose, and maintain product and subsystem requirements from cross-functional inputs.
• Create Design History File elements and maintain traceability between requirements, design entities, and verification activities.
• Plan and execute system integration activities and develop integration test plans, protocols, and reports.
• Manage deliverables from subsystem design teams and external partners and provide supplier technical guidance.
• Resolve systems-related technical issues using structured problem-solving tools.

Compliance Responsibilities

• Coordinate standards compliance activities, compliance plans, testing, results reviews, and certification projects.
• Develop product requirements and compliance strategies with hardware, mechanical, software, regulatory, and program teams.
• Coordinate certification inputs across regulatory, R&D, manufacturing, service, and external laboratory partners.
• Prepare standards test reports and submit documentation to regulatory authorities for global product certifications.
• Monitor changes to medical product standards and regulations and identify compliance and reliability risks.
• Support EMC investigations, diagnostics, and root-cause analysis with sustaining and design teams.

Required Qualifications

• Graduate or postgraduate qualification in biomedical, mechanical, electrical, electronics, or related engineering.
• 8–10 years of relevant technical experience defining systems and requirements for medical products.
• Experience developing electromechanical systems, preferably medical devices or highly regulated products.
• Strong knowledge of engineering disciplines including electromechanical systems, systems engineering, fluid mechanics, and materials science.
• Experience with requirements management, configuration management, defect tracking, and traceability.
• Strong analytical, communication, teamwork, time-management, and multitasking abilities.

Compliance and Technical Knowledge

• Hands-on experience with EMI/EMC standards, testing, regulations, and medical device certification procedures.
• Hands-on experience with IEC 60601 safety standards and related collateral and particular standards.
• Knowledge of wireless standards and regulations including ETSI, FCC, IC, and RED.
• Familiarity with FDA design controls, software validation, EU MDR, and ANSI/IEEE EMC standards.
• Experience with EMC design tools, automated EMC testing tools, scopes, and logic analyzers.
• Experience interfacing with regulatory agencies, conformity assessment bodies, and standards organizations.

Workplace

• Baxter’s flexible workplace policy includes a minimum of three days per week onsite.
• The role includes compliance testing at onsite facilities and external test laboratories.

Benefits Mentioned

• The posting mentions professional development, health and well-being benefits, paid time off, and volunteer time.