Principal R&D Mechanical Engineer, Therapy Delivery Systems

Principal R&D Mechanical Engineer, Therapy Delivery Systems

Boston Scientific is seeking a highly collaborative and strategically minded Principal R&D Mechanical Engineer to lead the effort of bringing our next generation therapy delivery systems to market. The successful candidate will provide technical guidance and product development process experience as the team designs and develops the next generation catheter-based delivery system for our Mechanical Circulatory Support (MCS) pump.

This candidate will work intimately with the catheter design team, guiding design decisions and working through the development process. Additionally, they will work collaboratively with our cross functional partners to scope and strategize: verification and validation, manufacturability, usability, quality and safety, and packaging.

At Boston Scientific, we value collaboration and synergy. This role follows the in-office model, requiring employees to be in our local office in Arden Hills, MN at least four days per week.

Your responsibilities will include:

• Providing technical subject matter expertise in the area of catheter and delivery system development.
• Provide guidance to team regarding formal product development activities required for Class II medical devices
• Be hands-on and engaged with the project team, driving multiple technical lanes simultaneously and prioritizing appropriately.
• Leading the design & execution of structured experimental plans to drive data-based decisions.
• Facilitating crisp decision making on key technical issues.
• Creating a strong team culture of high expectations and high performance
• Interfacing with Physicians/Cath Lab personnel to obtain feedback on concepts and performance of new solutions.
• Providing clear communication to stakeholders at key technical updates
• Understanding the anatomy, clinical use cases and user interface requirements to drive design decisions.
• Be current on latest catheter materials and fabrication techniques, incorporating these into competitive design solutions.
• Develop a strong internal and external network, leveraging that network to deliver results for the program.
• Provide technical guidance to technicians/entry-mid-level engineers.
• Be a strong team player, collaborating across process development, quality, manufacturing, regulatory, clinical, and marketing on complex projects to ensure project success.

Required qualifications:

• BS in Mechanical, Biomedical Engineering, or similar field.
• Required minimum years of work experience (primarily in medical device or related field): 7+ Years with BS, 5+ Years with MS.
• Demonstrated ability to provide technical solutions on a large-scale development program.
• At least one year of experience in the catheter/delivery system space.
• Experience navigating a commercial product development process within the medical device space
• Solid clinical knowledge and experience in cardiovascular and peripheral anatomy.
• Experience managing technical aspects of projects as a member of a cross-functional team.
• Excellent organizational, communication and collaboration skills.
• A solid understanding of critical catheter-based product performance metrics.

Preferred qualifications:

• MS in related technical field.
• Experience developing solutions within a complex device system.
• 510(k), Class II or Class III Medical Device product development experience.
• Solid experimental design and statistical analysis knowledge
• Deep understanding of catheter and delivery system materials and technologies.
• Knowledge and experience in advanced prototyping and fabrication techniques, and ability to distill several technical concepts into a robust solution.
• Ability to draw conclusions and make recommendations based on technical inputs from multiple and varied sources.
• A proven ability to deliver robust technical solutions to complex engineering problems.