Lead Medical Device R&D Engineer — Hybrid

cardinalhealth; Hazelwood (MO); Hybrid; USD 81,000 - 103,000; Full time

Benefits offered by this job

Medical, dental and vision coverage

Paid time off plan

401k savings plan

HSA

Job summary

Cardinal Health in Hazelwood, MO is seeking a Senior R&D Engineer to lead the design, development, testing, and refinement of electromechanical medical devices such as enteral feeding pumps, thermometers, and compression devices. You will develop test methods, oversee execution, analyze data, and ensure compliance with global standards.

The role emphasizes cross-functional teamwork with marketing, regulatory, clinical, and sourcing, plus coordinating with manufacturers and vendors worldwide.

Qualifications

• Bachelor's degree in related field preferred or relevant work experience
• Preferred certifications: LSS Green Belt, DFSS
• 2+ years of experience in medical device product development preferred
• Demonstrated experience with full lifecycle design control processes (e.g., 21 CFR Part 820.30, ISO 13485).
• Proven experience in developing, validating, and executing test procedures for medical devices, preferred.
• Strong background in statistical analysis for engineering applications (e.g., Minitab, JMP), preferred
• Ability to work independently and in team setting
• Strong written and verbal communication skills, with the ability to present complex technical information clearly to diverse audiences.
• Travel Expectations: 25%

Responsibilities

• Product Development: Drive the full lifecycle execution of complex product development projects from concept through commercialization, ensuring adherence to timelines, budget, and quality standards.
• Advanced Troubleshooting & Analysis: Troubleshoot and resolve intricate technical issues related to concept designs and products. Utilize advanced statistical analysis techniques (e.g., ANOVA, regression analysis, Monte Carlo simulations) to identify root causes, optimize performance, and implement design improvements.
• Test Method Development & Validation: Design, develop, and validate comprehensive test protocols and methods that comply with FDA, European, and other relevant international medical device standards. Oversee test execution and author detailed, high-quality test reports.
• Design Control & Documentation: Create, review, and approve critical project documentation, including design specifications, protocols, engineering drawings, and design history file (DHF) elements, ensuring compliance with design control procedures.
• Cross-Functional Collaboration & Leadership: Act as a key technical liaison, fostering strong partnerships with internal teams (e.g., Marketing, Regulatory Affairs, Clinical, Sourcing) and external stakeholders, including global manufacturers, business partners, and vendors, to ensure seamless project execution and success.
• Customer-Centric Innovation: Actively participate in discovering and articulating unmet customer and clinical needs, translating these insights into innovative product requirements and design solutions.

Job description

Cardinal Health in Hazelwood, MO is seeking a Senior R&D Engineer to lead the design, development, testing, and refinement of electromechanical medical devices such as enteral feeding pumps, thermometers, and compression devices. You will develop test methods, oversee execution, analyze data, and ensure compliance with global standards.

The role emphasizes cross-functional teamwork with marketing, regulatory, clinical, and sourcing, plus coordinating with manufacturers and vendors worldwide.