Principal Mechanical Engineer; Console System

About the role

Principal Mechanical Engineer – responsible for technical leadership in 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.

Onsite in Carlsbad, CA; requires presence in the local office to support hands‑on system integration, test execution, and cross‑functional collaboration.

Relocation assistance is not available for this position at this time.

Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time.

• 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+ years of experience developing complex medical devices, electromechanical systems, or highly regulated products.
• Demonstrated experience leading mechanical design activities from concept through commercialization.
• Experience developing and supporting Class II and/or Class III medical devices.
• Strong expertise in mechanical design, GD&T, tolerance analysis, materials selection, and assembly design.
• Proficiency with CAD systems such as Solid Works or equivalent mechanical design software.
• Experience performing engineering analyses including FEA, tolerance stack analysis, and statistical evaluation techniques.
• Experience…