Principal Mechanical Engineer (Console System)

Boston Scientific•Carlsbad, CA

6d•$106,800 - $202,900•Onsite

About The Position

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.

Requirements

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.

Nice To Haves

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.

Responsibilities

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.

Benefits

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.
Travel up to approximately 10-20% to support development activities, testing, supplier interactions, and cross-site collaboration.
The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) – see www.bscbenefitsconnect.com—will vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role.
Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs.
At BSC, it is not typical for an individual to be hired near the bottom or top of the anticipated salary range listed above.
Compensation for non-exempt (hourly), non-sales roles may also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).
Compensation for exempt, non-sales roles may also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).
Certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status.
Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements.
As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.
Among other requirements, Boston Scientific maintains specific prohibited substance test requirements for safety-sensitive positions.
This role is deemed safety-sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement.
The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law.