R&D Engineer

Position Summary We are seeking an experienced Senior R&D Engineer to support the development and commercialization of innovative medical device products. This individual will play a key role in product development activities from concept through design transfer, collaborating with cross-functional teams to develop robust products and processes that meet customer, business, and regulatory requirements.The ideal candidate will possess approximately 10-12 years of engineering experience within the medical device industry, with a track record of leading technical projects, solving complex engineering challenges, and supporting product development in a regulated environment. Key Responsibilities Lead product development activities throughout the design and development lifecycle.Develop engineering solutions to support new product development and continuous product improvement initiatives.Generate design concepts, test plans, technical documentation, and engineering analyses.Collaborate with Quality, Manufacturing, Regulatory Affairs, Clinical, and Operations teams to ensure successful project execution.Support risk management activities, including design reviews and product risk assessments.Plan and execute verification and validation testing to ensure product performance requirements are met.Analyze engineering, product, and test data to support design decisions and recommendations.Participate in design transfer activities and support manufacturing readiness efforts.Investigate and resolve technical issues through structured problem-solving methodologies.Contribute to project planning, technical decision-making, and cross-functional team discussions.Ensure compliance with applicable quality systems, design control requirements, and regulatory standards.Mentor junior engineers and provide technical guidance across project teams. Qualifications Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Chemical Engineering, Materials Engineering, or related engineering discipline.Approximately 10-12 years of engineering experience, preferably within the medical device, biotechnology, or other regulated product industries.Experience supporting product development activities from concept through commercialization.Knowledge of design control processes, verification and validation, and risk management principles.Experience working in a regulated environment governed by FDA, ISO 13485, or similar standards.Strong technical problem-solving, analytical, and troubleshooting skills.Demonstrated ability to lead complex projects and influence cross-functional teams.Excellent written, verbal, and interpersonal communication skills. Preferred Experience Class II or Class III medical device development experience.Experience with design verification, validation, and statistical data analysis.Familiarity with materials, manufacturing processes, or device testing methodologies.Participation in design reviews, product risk assessments, and technical documentation development.Experience supporting product launches, design transfers, or sustaining engineering initiatives.