R&D Systems Engineer II

About the role 

Our engineers play a crucial role in all aspects of medical device development, including concept generation, design, prototyping, and manufacturing transfer. This position offers the unique opportunity to integrate systems engineering principles into the development process, ensuring that all components work harmoniously to meet regulatory and clinical requirements. You will collaborate with government bodies to obtain regulatory approval and work with the IP department to issue patents, contributing to innovative solutions in the medical device sector. 

Your Responsibilities Will Include: 

• Assist in the design of cutting-edge medical devices through prototyping, testing, and modeling, with a focus on systems integration and performance optimization. 

• Participates on project teams to translate user needs into design requirements (e.g. system, hardware, software, firmware, mechanical, electrical, interface, etc.) consisting of system/sub-system specifications. 

• Develop validation plans and conduct validation testing to ensure that all systems meet stringent safety and efficacy standards. 

• Collaborate on Design for Manufacturing (DFM) activities to ensure that designs are optimized for production efficiency and cost-effectiveness. 

• Develop and test new manufacturing processes, ensuring they align with both engineering specifications and regulatory guidelines. 

• Maintain strong working relationships with suppliers to facilitate the integration of complex components into the overall system. 

• Support regulatory filings to various government bodies, ensuring compliance with applicable standards and regulations. 

• Contribute to the development of intellectual property by identifying and protecting novel design solutions and engineering processes. 

• Support pre-clinical and clinical research activities, ensuring that system-level performance is validated in real-world scenarios. 

• Comply with the Health & Safety policies of the company and inform management of unsafe working conditions. 

• Other duties as required. 

Required Qualifications: 

• Bachelor’s degree in Electrical Engineering, Systems Engineering, or a related field. 

• 3+ years of experience with product development activities in a regulated industry, specifically in the medical device sector. 

• Knowledge of design requirements as per ISO 13485 and other relevant regulatory standards. 

• Experience leading rapid design iterations and making informed design recommendations based on systems-level analysis. 

• Ability to independently develop and adapt work plans based on vague or changing project goals, employing a systems engineering approach. 

• Strong hypothesis-driven experimental design and statistical analysis skills to assess system performance. 

• Candidates should be self-starters with a hands-on approach to systems integration. 

• Ability to work both independently and collaboratively within a diverse group of engineers and production staff. 

• Strong communication skills (verbal/written) and demonstrated leadership capabilities in cross-functional teams. 

Preferred Qualifications: 

• Related experience in the medical device industry; candidates from automotive, aerospace, and other biotechnology sectors are welcome. 

• Excellent organizational, communication, and collaboration skills, with the ability to contribute effectively to team objectives. 

• Proven ability to work efficiently both as part of a team and independently. 

Learn more about our Transseptal Access Devices  

Click this link to explore the groundbreaking technology behind our transseptal access devices at Boston Scientific: Transseptal access devices.