Job DescriptionWe are seeking an experienced Sr. Electrical Engineer to support the development of innovative drug-device combination products and connected medical technologies within our Combination Product Development team in R&D. In this role, you will lead and support electrical engineering activities for advanced drug delivery and medical device systems, with particular emphasis on connected and intelligent devices leveraging IoT, AI-enabled engineering approaches, Bluetooth, Wi-Fi, NFC, NB-IoT, and related wireless technologies.
This position will contribute to the development of new device and platform technologies, ensuring strong technical execution and compliance with applicable quality and regulatory requirements. The individual will work closely with cross-functional engineering and development teams, as well as external partners, throughout the product development lifecycle.
Responsibilities
Design and Development
- Lead and support electrical and electronic design activities for drug delivery systems, connected devices, and other electromechanical medical products.
- Execute feasibility and early-stage development activities, including user needs translation, requirements development, concept evaluation, technology assessment, and system architecture definition.
- Evaluate electrical system architectures, including sensing, power, embedded electronics, communications, and subsystem integration.
- Perform electronics design assessments, including circuit design, PCB review, component selection, design margin analysis, and test strategy development.
- Support development of connected device architectures incorporating Bluetooth, NFC, NB-IoT, Wi-Fi and related wireless communication technologies.
- Contribute to robust, manufacturable, scalable designs from concept through clinical development and commercial launch.
Technical Analysis and Validation
- Support system integration, reliability assessments, verification testing, and design validation activities.
- Develop and support engineering documentation, including design inputs, design outputs, protocols, risk assessments, FMEAs, and traceability documentation.
- Partner with lab and verification teams on test methods, test setups, engineering investigations, and confidence testing.
- Review schematics, PCB layouts, and interface definitions to identify technical risks and recommend solutions.
- Support troubleshooting, root cause analysis, complaint investigations, and reliability assessments for development and fielded products.
- Ensure designs address electrical safety, EMC, manufacturability, testability, and long-term reliability.
Connected Systems and Digital Capability
- Drive evaluation and application of connected medical device technologies that improve usability, adherence, data access, and system intelligence.
- Contribute to development of devices that interface with digital health ecosystems, mobile applications, cloud-connected environments, and remote monitoring platforms.
- Apply appropriate IoT architectures, connectivity strategies, and cybersecurity-aware design principles for regulated medical products.
- Provide technical depth in wireless and short-range communication technologies, especially Bluetooth, NFC, Wi-Fi and NB-IoT.
- Evaluate and leverage AI-assisted engineering tools and intelligent development methods to improve design, analysis, prototyping, and testing workflows.
Cross-Functional Collaboration
- Collaborate with clinical, regulatory, quality, operations, software, systems, and mechanical engineering teams, as well as external development partners.
- Work across engineering disciplines to drive technical alignment and execution of integrated product solutions.
- Partner with stakeholders to ensure development deliverables, documentation, and timelines meet quality and regulatory expectations.
- Support technical reviews with suppliers, contract manufacturers, and external partners.
Continuous Improvement
- Maintain awareness of emerging technologies relevant to combination products, connected devices, and digital health.
- Monitor industry trends in IoT, AI-enabled engineering, wireless medical systems, and connected care technologies.
- Contribute to continuous improvement initiatives focused on engineering quality, process efficiency, and innovation.
- Apply appropriate project management and stage-gate development practices to support successful execution.
Qualifications- BS in Electrical Engineering or equivalent discipline with typically 10+ years of relevant industry experience; or MS in Electrical Engineering or equivalent discipline with typically 8+ years of relevant experience.
- Demonstrated experience in medical devices, drug-device combination products, or other regulated electromechanical systems.
- Strong experience designing and developing electrical systems from concept through verification, validation, and product launch.
- Experience with connected medical devices, digital health technologies, or wireless-enabled products is highly desirable.
- Experience working with external development partners, suppliers, and cross-functional product development teams is preferred.
Technical Skills
- Expertise in analog, digital, and mixed-signal electrical system design.
- Strong understanding of embedded systems, microcontrollers, communication interfaces, and subsystem integration.
- Experience with circuit design, PCB design and review, schematic capture, component selection, and design for manufacturability/testability.
- Strong knowledge of communication protocols such as SPI, I2C, UART/RS-xxx, USB, and related embedded interfaces.
- Experience with wireless and IoT technologies, especially Bluetooth, NFC, Wi-Fi and NB-IoT.
- Experience evaluating or developing connected device architectures in medical or regulated product environments.
- Understanding of IEC 60601, IEC 60601-2-24, 21 CFR 820.30, ISO 13485, ISO14971 and related medical device standards and requirements.
- Experience with design verification and validation in regulated environments.
- Proficiency with engineering tools, lab equipment, simulation tools, and analytical problem-solving methods.
- Experience using AI-assisted tools to enhance engineering productivity is desirable.
Competencies
- Strong technical leadership and engineering judgment.
- Ability to solve complex problems involving multiple design constraints and tradeoffs.
- Excellent cross-functional collaboration and communication skills.
- Strong project management capability and ability to manage multiple priorities.
- Proactive approach to identifying and resolving technical and project risks.
- Self-motivated with the ability to work independently and effectively within teams.
Key Stakeholders
- R&D engineering teams, including electrical, software, systems, and mechanical engineering
- Regulatory Affairs and Quality Assurance
- Operations, Manufacturing, and Supply Chain
- Clinical and Commercial teams
- External development partners, suppliers, and contract manufacturers
- Project and cross-functional leadership across internal and external development ecosystems in a regulated environment
Additional InformationApplicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
- The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
- We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
- This job is eligible to participate in our long-term incentive programs.
Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law.
