OEM R&D Sr. Staff Engineer

Lead the full product lifecycle for medical device solutions within a regulated R&D environment, from concept through validation and ongoing support. Collaborate with customers and cross-functional teams to define requirements, apply FDA 21 CFR Part 820, ISO 13485, and ISO 14971, and ensure robust risk management. Role requires strong project leadership, CAD proficiency (SolidWorks preferred), and 6–8 years of experience in a manufacturing/engineering setting. Responsibilities include developing and improving industrial manufacturing methods, planning workflow and equipment layouts for efficiency, estimating production times and costs, communicating production capabilities and schedules, engaging with vendors on specifications and parts, and evaluating products against specifications and quality standards. The job emphasizes safety, regulatory compliance, and the ability to operate in a fast-paced, collaborative environment.