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Agent guide: [/agents.md](https://www.wearedevelopers.com/agents.md). --- # Principal Mechanical Engineer (Console System) - **Company:** Boston, Inc. - **Location:** Carlsbad, CA, United States - **Experience:** Expert - **Salary:** $106,800.0 - $202,900.0 - **Contract:** Permanent contract - **Skills:** Computer-Aided Design, Systems Engineering, SolidWorks (CAD), Software Requirements Analysis, Verification and Validation (Software), Systems Integration, Test Execution Engine, Iq/oq/pq - **Published:** July 18, 2026 - **Apply:** https://diversityjobs.com/main/sendform/8/8/28176/1/17627779?backUrl=%2Fcareer%2F17627779%2FPrincipal-Mechanical-Engineer-Console-System-California-Carlsbad ## About the Role * 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 SolidWorks or equivalent mechanical design software. * Experience performing engineering analyses including FEA, tolerance stack analysis, and statistical evaluation techniques. * Experience developing test methods, fixtures, tooling, and characterization methodologies. * Working knowledge of manufacturing processes, process development, and design transfer activities. * Experience working within Design Controls and Quality Management Systems compliant with FDA regulations and ISO 13485. * Experience supporting verification and validation activities, technical documentation, engineering reports, and requirements-based development. * Experience supporting regulatory submissions and technical interactions associated with FDA-regulated medical devices. * Strong analytical, problem-solving, communication, and technical leadership skills. * Demonstrated ability to work effectively across multidisciplinary engineering organizations., * Advanced degree (MS or equivalent) in Mechanical Engineering, Biomedical Engineering, Optical Engineering, Physics, or related discipline. * Experience developing capital medical equipment and disposable catheter-based products as part of a complete medical device system. * Experience with laser energy delivery systems, optical assemblies, fiber optic technologies, or optomechanical design. * Experience with Class 3B and Class 4 laser systems and associated energy delivery architectures. * Experience developing intravascular, catheter-based, cardiovascular, or other minimally invasive medical devices. * Familiarity with risk management methodologies and standards such as ISO 14971. * Experience supporting PMA and/or 510(k) submissions. * Experience developing products that integrate mechanical, electrical, software, and optical technologies. * Experience leading complex technical projects across global or multi-site development teams. * Strong understanding of clinical workflows and translating user needs into robust engineering solutions. ## Description 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 be responsible for translating 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 requires a deep understanding of mechanical engineering principles, medical device development, electromechanical systems, design controls, and the interface between reusable capital equipment and single-use disposable devices. The ideal candidate will possess strong analytical capabilities, hands-on development experience, and the ability to influence technical direction across multiple cross-functional teams. Work Mode 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. ## Related Videos - [Model Based Systems Engineering in an Agile Product Development Process](https://www.wearedevelopers.com/videos/68-model-based-systems-engineering-in-an-agile-product-development-process) - [XR Demystified: Separating Facts from Fiction in 2024](https://www.wearedevelopers.com/videos/1117-xr-demystified-separating-facts-from-fiction-in-2024) - [From Bedside Beeps to Interoperable Bytes – Getting your medical devices ready to talk the IEEE 11073 language](https://www.wearedevelopers.com/videos/771-from-bedside-beeps-to-interoperable-bytes-getting-your-medical-devices-ready-to-talk-the-ieee-11073-language) - [Breaking the Hardware Mindset: Overcoming Barriers to System-Level Innovation](https://www.wearedevelopers.com/videos/1635-breaking-the-hardware-mindset-overcoming-barriers-to-system-level-innovation) - [Automated Driving - Why is it so hard to introduce](https://www.wearedevelopers.com/videos/628-automated-driving-why-is-it-so-hard-to-introduce) - [Google Gemma and Open Source AI Models - Clement Farabet](https://www.wearedevelopers.com/videos/1354-google-gemma-and-open-source-ai-models-clement-farabet) ## Related Articles - [Are Brain-Computer Interfaces Good or Bad?](https://www.wearedevelopers.com/magazine/367-are-brain-computer-interfaces-good-or-bad) - [Is Software Engineering Hard?](https://www.wearedevelopers.com/magazine/448-is-software-engineering-hard) - [What Jobs Can You Get with a Software Engineering Degree?](https://www.wearedevelopers.com/magazine/398-what-jobs-can-you-get-with-a-software-engineering-degree) - [What is Software Engineering?](https://www.wearedevelopers.com/magazine/289-what-is-software-engineering) - [Software Engineer Salary London](https://www.wearedevelopers.com/magazine/252-software-engineer-salary-london) - [What Makes WeAreDevelopers World Congress Different From Every Other Tech Event?](https://www.wearedevelopers.com/magazine/701-what-makes-wearedevelopers-world-congress-different-from-every-other-tech-event)