Boston Scientific - Santa Clarita, CA

posted 4 months ago

Full-time - Senior
Santa Clarita, CA
Miscellaneous Manufacturing

About the position

We are seeking a highly experienced Technical Fellow, HW Systems Design Engineer to join the Boston Scientific Neuromodulation R&D team. As a technical leader, you will play a critical role in guiding the transition and progress of electro-mechanical systems and platform visions from concept to product launch. You will work closely with cross-functional teams, balancing user needs, market opportunity, and business requirements. Your expertise and leadership will drive the integration of technical functions and capabilities into the product and system, while collaborating with stakeholders to define technology and feature roadmaps. In this hybrid role, located in the Valencia, CA area, you will be required to work in the office three days per week. Your responsibilities will include designing and architecting Neuromodulation Product Systems with a focus on hardware systems. You will provide technical leadership on cross-functional technology development, product development, and engineering teams. Additionally, you will design and establish product and commercial system architectures in collaboration with technical and cross-functional core teams and stakeholders. You will act as an R&D representative on cross-functional deliverables, collaborating with stakeholders outside R&D to understand current and future market needs and incorporate these inputs into platform designs that are forward-looking. Your role will also involve translating high-level customer, business, and manufacturing needs into technical requirements, ensuring effective development and support of hardware, ASIC, mechanical, electrode/lead, and software systems and associated interfaces. You will create, establish, and document system architectures and design control elements, define and analyze system requirements, clinical workflows, and input/output processes using systems engineering methods, and identify technical risks while developing risk burndown plans. Moreover, you will create and support documentation as part of the Product Development Process (PDP) and Quality Management System, provide expertise and guidance for validation and verification activities, and guide projects to meet industry-based standards while aiding in the creation of internal standards. You will collaborate with Program Managers to plan and execute projects within timelines and budget, drive mechanisms for detailed project planning, tracking, and issue identification, and manage technical dependencies and critical path items. Your leadership will extend to mentoring a team of systems engineers on systems engineering best practices, upholding the highest degree of technical rigor throughout all program phases.

Responsibilities

  • Designer & architect of Neuromodulation Product Systems with a focus on HW systems.
  • Provide technical leadership on cross-functional technology development, product development, and engineering teams.
  • Design and establish product and/or commercial system architectures in collaboration with technical and cross-functional core teams and stakeholders.
  • Act as an R&D representative on cross-functional deliverables.
  • Collaborate with stakeholders outside R&D to understand current and future market needs and incorporate these inputs into platform designs that are forward-looking.
  • Translate high-level customer, business & manufacturing needs into technical requirements.
  • Ensure effective development and support of hardware, ASIC, mechanical, electrode/lead and software systems and associated interfaces.
  • Create, establish, and document system architectures and design control elements.
  • Define and analyze system requirements, clinical workflows, and input/output processes using systems engineering methods.
  • Identify technical risks, develop risk burndown plans, and implement phased system integration approaches to mitigate risk.
  • Create and support documentation as part of the Product Development Process (PDP) and Quality Management System.
  • Provide expertise and guidance for validation and verification activities.
  • Guide projects to meet industry-based standards & aid in the creation of internal standards.
  • Collaborate with Program Managers to plan & execute projects within timelines & budget.
  • Drive mechanisms for detailed project planning, tracking, and issue identification.
  • Drive program-related technical risks and spearhead the creation of comprehensive risk mitigation and contingency plans across R&D functions.
  • Manage technical dependencies and critical path items.
  • Liaise with project team members, stakeholders and upper-level management to effectively communicate project expectations, status, and deliverables.
  • Lead and mentor a team of systems engineers on systems engineering best practices.
  • Uphold the highest degree of technical rigor and guide the team to follow technical rigor throughout all program phases.

Requirements

  • BS in Engineering or Science
  • 10+ years of work experience with BS, 8+ years with MS, 5+ years with PhD
  • Demonstrated experience translating ambiguous and high-level customer, end user, business, and manufacturing needs into technical requirements.
  • Experience in creating and aligning stakeholders to a vision, strategy & designs for technology efforts that span multiple products.
  • Experience designing system-of-systems architecture, sub-system definition, interface definition, and integration.
  • Experience driving electrical, mechanical and system miniaturization.
  • Experience working with medical device microprocessor, ASIC or SOC (system on chip) system architecture.
  • Experience in leading system characterizations and trade-offs analyses for power budgets, data storage/transmission, battery selection, BLE antenna designs, lead/electrode designs for various use cases.
  • Experience in developing and implementing HW sensors (Ex. accelerometers) into closed loop systems involving multiple hardware, firmware, and algorithm modules.
  • Knowledge of electrode development and integration into hardware systems.
  • Strong experience with advanced statistics, including T-Test, ANOVA, Design of Experiments (DOEs), Response Surface analysis, multi-variate analysis, population analysis techniques, probability, 6 Sigma, Monte Carlo analysis, etc.
  • Expertise in test method development, Gage R&R and establishing performance metrics.
  • Black Belt Certification in Lean Sigma, Six Sigma, DRM, Design for X (DFM, DFR, DfSS, etc.).
  • Experience in leading technical and architecture trade-offs to optimize design, performance, usability, manufacturability, cost-efficiency and reliability.
  • Experience in integration and overseeing collaboration among hardware, mechanical, electrical, algorithms and software teams.
  • Experience in algorithm and firmware development and product implementation.
  • Experience designing, developing and launching hardware-cloud-app systems.
  • Experience leading R&D team failure analysis investigations, root cause identification and driving process/product improvements.
  • Proficiency in project management and project management tools (e.g., MS Project, JIRA).
  • Experience in the medical device, aerospace, electronics, or other advanced technology and/or regulated industries.

Nice-to-haves

  • Experience in leading technical and architecture trade-offs to optimize design, performance, usability, manufacturability, cost-efficiency and reliability.
  • Experience in integration and overseeing collaboration among hardware, mechanical, electrical, algorithms and software teams.

Benefits

  • Annual bonus target (subject to plan eligibility and other requirements)
  • Core and optional employee benefits
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