
Senior System Verification Engineer
- Heredia
- Permanente
- Tiempo completo
- 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 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 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.
- 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.
- 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.
- 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.
- 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.
- 2+ years of work experience in a regulated environment, preferably in the Medical Industry.
- 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.
- 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.
- Strong experience with advanced statistics, including T-Test, ANOVA, Gage R&R, Design of Experiments (DOEs), Response Surface analysis, probability, 6 Sigma, etc.
- 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.
- 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.