Principal Mechanical Engineer; Console System

Principal Mechanical Engineer (Console System)

Location:

Carlsbad, CA, US, 92011

The Principal Mechanical Engineer will provide technical leadership for the design, development, integration, and commercialization of Boston Scientific’s next-generation Intravascular Lithotripsy (IVL) platform within the Interventional Cardiology and Vascular Therapies (ICVT) division. This role is responsible for performing the mechanical engineering efforts across a complex medical device system consisting of capital equipment (console/generator), laser and optical subsystems, and electromechanical assemblies.

As a senior technical contributor, you will translate clinical and system requirements into robust mechanical designs and manufacturing solutions while driving product performance, reliability, manufacturability, and cost optimization throughout the product lifecycle. You will partner closely with systems, software, electrical, optical, manufacturing, quality, regulatory, clinical, and supply chain teams to develop innovative Class II and Class III medical devices from concept through commercialization.

This role is onsite, requiring employees to work from the local office in Carlsbad, CA to support hands-on system integration, test execution, and cross-functional collaboration.

• Lead the mechanical design and development of complex medical device systems, subsystems, assemblies, and components from concept through commercialization.
• Serve as the technical lead for mechanical engineering activities supporting Boston Scientific's IVL platform.
• Develop innovative mechanical architectures that enable reliable interaction between reusable console systems and disposable catheter-based devices.
• Generate mechanical concepts, prototypes, and detailed designs using modern CAD tools and engineering best practices.
• Perform and guide engineering analyses including tolerance stack analysis, finite element analysis (FEA), statistical analysis, and reliability assessments to ensure product performance and robustness.
• Define and execute mechanical characterization, verification, and validation strategies to support system-level requirements and product performance objectives.
• Collaborate with systems engineering to translate user needs and system requirements into mechanical design specifications and design outputs.
• Drive design-for-manufacturability (DFM), design-for-assembly (DFA), design-for-serviceability, and design-for-reliability initiatives throughout product development.
• Design and develop test fixtures, tooling, and manufacturing equipment required to support product verification, process development, and commercialization activities.
• Support manufacturing transfer activities, process qualification, and sustained production efforts while ensuring robust product performance and yields.
• Partner with suppliers and external development partners to ensure successful development, qualification, and supply of critical components and assemblies.
• Lead root cause investigations, risk assessments, and corrective actions related to product design, manufacturing issues, and field performance.
• Support design control activities including requirements development, risk management, design reviews, traceability, verification, validation, and design history file documentation.
• Contribute technical expertise to regulatory submissions, engineering justifications, responses to regulatory authority inquiries, and product lifecycle management activities.
• Mentor and provide technical guidance to engineers across multiple disciplines while fostering engineering excellence and innovation.
• Drive continuous improvement efforts focused on product performance, reliability, manufacturability, and cost optimization.
• Build strong relationships across cross-functional and multi-site teams to ensure alignment on technical objectives, schedules, and program deliverables.
• Travel up to approximately 10-20% to support development activities, testing, supplier interactions, and cross-site collaboration.

• Bachelor's degree in Mechanical Engineering or related engineering discipline (or equivalent experience).
• 7+…