Boston Scientific Principal Manufacturing Engineer External Products - Hybrid 

United States, Massachusetts, Marlborough 

993095116

Costa Rica-Heredia

About the role

We are seeking a highly experienced Senior System Verification Engineer to join the Boston Scientific Neuromodulation R&D team. As a key member of the team, you will play a critical role in ensuring the reliability and performance of our neuromodulation systems through rigorous verification processes. You will work closely with cross-functional teams to verify features and system functionality against design requirements. Your expertise will drive the development and execution of comprehensive system level verification strategies, while collaborating with stakeholders to define design requirements and test methodologies.

This is a Hybrid role, located in Heredia and will require 3 days per week in the office.

Lead System Design Verification:

• Lead the verification of implantable and external Neuromodulation Product Systems with a focus on hardware/software integrated systems.
• Develop and implement verification plans, protocols, and test cases to ensure product compliance with design specifications and regulatory requirements.

Provide Technical Leadership:

• Provide technical leadership on cross-functional verification efforts, including hardware, software, and system-level testing. Act as an R&D representative on cross-functional deliverables, ensuring alignment with verification objectives.

Collaborate with Stakeholders:

• Collaborate with stakeholders outside R&D to understand current and future market needs and incorporate these inputs into verification strategies. Translate high-level customer, business, and manufacturing needs into detailed verification requirements.

Develop and Support Verification Tools and Processes:

• Ensure effective development and support of verification tools, test environments, and automated test systems.
• Create, establish, and document verification processes and methodologies.
• Provide expertise and guidance for validation and verification activities.

Risk Management and Project Planning:

• Identify technical risks, develop risk mitigation plans, and implement phased verification approaches to mitigate risk.
• Act as a Technical Project Manager within the Systems Engineering function on assigned programs, performing detailed project planning, resource and budget planning, tracking, dependency and issue identification, and reporting.
• In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.

For those individuals that supervise others, the following statements are applicable:

• Assures that appropriate resources (personnel, tools, etc.) are maintained in order to assure Quality System compliance and adherence to the BSC Quality Policy.
• Establishes and promotes a work environment that supports the Quality Policy and Quality System.

Education and Work Experience:

• Bachelor’s degree or more from an accredited school in Electrical Engineering, Computer Engineering, Electromechanical Engineering, Systems Engineering, Computer Science, or related field.
• 5+ Years of work experience in engineering with a Bachelor’s degree.

Experience in a Regulated Environment:

• 2+ years of work experience in a regulated environment, preferably in the Medical Industry.

Translating High-Level Needs into Detailed Requirements:

• Experience translating ambiguous and high-level customer, end user, business, and manufacturing needs/requirements into detailed verification/test objectives, protocols & scripts.
• Ensure that the verification process aligns with the overall goals and needs of the stakeholders.

Designing Verification Strategies:

• 2+ years of experience designing verification strategies for system-of-systems architecture, system interfaces, and integration.
• Develop comprehensive verification plans that address the complexities of integrated systems.

Advanced Statistical Analysis:

• Strong experience with advanced statistics, including T-Test, ANOVA, Gage R&R, Design of Experiments (DOEs), Response Surface analysis, probability, 6 Sigma, etc.

Technical Leadership and Stakeholder Alignment:

• 2+ years of experience in creating and aligning stakeholders to a vision, strategy, and designs for verification efforts that span multiple products.
• Lead cross-functional teams and ensuring that verification strategies are aligned with business and technical goals.
• Experience with automated testing frameworks.
• Knowledge of programming/scripting languages such as Python, C++, LabView, Matlab.
• Solid understanding of EE concepts (Ohms law, DSP, analog / digital electronics)
• Ability to Architect Test Environments and experience with version control systems (e.g., Git), Dev Ops and CICD methodologies.
• Understanding of hardware-software integration.
• Fluent on the use of EE test equipment like oscilloscope, function generators, DAQ equipment.

Desired Requirements:

• 1+ years of direct experience working in the Technology Development (TDP) and Product Development (PDP) phases of the product lifecycle.
• Experience working with medical device microprocessors, ASIC, or SOC (system on chip) system architecture.
• Experience participating in 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 delivering software products both as a Medical Device (SaMD) and in a Medical Device (SiMD).
• Experience with Data Privacy and Cybersecurity for connected medical product systems.
• Experience participating in integration and overseeing collaboration among hardware, mechanical, electrical, algorithms, and software teams.
• Experience in algorithm and firmware development and product implementation.
• Experience leading R&D team failure analysis investigations, root cause identification, and driving process/product improvements.