R&D Engineer II

Key Responsibilities

• Support product development activities from concept through design transfer and commercialization
• Develop product specifications, manufacturing methods, and technical documentation
• Lead and support Design Verification (DV), Validation, and V&V activities
• Execute equipment qualifications (IQ/OQ/PQ) and test method validations
• Perform hands-on laboratory testing, experimentation, troubleshooting, and data analysis
• Collaborate cross-functionally with Quality, Regulatory, Manufacturing, and Operations teams
• Support regulatory submissions and product improvements across existing product lines

Required Qualifications

• Bachelor's Degree in Engineering or related technical discipline
• 4+ years of Product Development experience within the Medical Device industry
• Experience developing Class II and/or Class III medical devices
• Strong understanding of Design Controls and regulated product development
• Experience with Design Verification (DV), Validation, and V&V activities
• Knowledge of DOE (Design of Experiments), Test Method Validation (TMV), and equipment qualification protocols (IQ/OQ/PQ)
• Experience using SolidWorks
• Strong analytical and problem-solving skills

Why This Opportunity Stands Out

This is an opportunity to get in on the ground floor of multiple next-generation projects while also supporting and improving an established portfolio of commercial products. You'll have the chance to work across the entire product lifecycle—from concept development and prototyping through design verification, validation, manufacturing transfer, and commercialization.