Product Development Engineer

Role: Product Development Engineer leading technical aspects of new or re-designed disposable medical devices in a regulated environment. Responsibilities include designing and developing devices following design control standards (e.g., 21 CFR 820, ISO 13485), conducting risk analysis, validation, and verification activities, and supporting quality and continuous improvement initiatives. Key tasks involve cross-functional collaboration with manufacturing, regulatory, marketing, and operations teams to transfer designs into production, develop test protocols, and ensure compliance. Qualifications: Bachelor’s in mechanical, biomedical, electrical engineering or related; 8+ years’ medical device R&D experience or 3-5 years product development experience in regulated industry; proficiency in SolidWorks, Microsoft Office, and familiarity with standards like ISO 13485 and ISO 14971. Soft skills include strong analytical, problem-solving, communication, and organizational abilities. HighValue: Medical devices, regulated environment, design control, risk management, cross-functional collaboration, validation/testing, continuous improvement. Work setup: not specified; supervisory responsibilities may include overseeing team members.