HS Design, Inc.
The Senior Electrical Engineer leads the design and integration of electrical systems for medical devices, spanning system architecture, PCB and circuit design, FPGA development, and prototyping. The role ensures designs meet performance, safety, and regulatory requirements while guiding verification and validation activities. The Senior Electrical Engineer collaborates across disciplines, mentors junior engineers, and drives continuous innovation to deliver high-quality solutions that advance healthcare technology and improve patient outcomes.
Key Responsibilities
Systems Architecture and Integration Define and lead system-level electrical architecture, including analog, digital, RF, power, and FPGA subsystems, ensuring robust integration across hardware, firmware, and mechanical domains. Perform trade-off analyses (performance, cost, power, reliability) and guide architectural decisions to meet product and regulatory requirements. Establish and maintain clear interface definitions and provide technical leadership in design reviews to ensure scalable and manufacturable solutions. Electrical Design and Development Lead the design, development, and testing of electrical systems and components for medical devices. Oversee schematic capture, PCB layout, and circuit analysis to ensure robust and manufacturable designs. Direct simulation and evaluation activities to verify design integrity, performance, and compliance with requirements. Prototyping and Testing Lead the creation and evaluation of prototypes and test fixtures to verify design specifications and functional requirements. Oversee electrical and system-level testing, including EMC/EMI, safety, and performance testing, ensuring results feed back into the design process. Interpret and analyze test data, driving design changes and guiding the team toward robust, compliant solutions. Leadership and Collaboration Provide technical leadership in project planning, architecture decisions, and design reviews, ensuring alignment with product requirements and business objectives. Mentor and guide junior engineers, fostering technical growth and a culture of quality and accountability. Work closely with cross-functional teams (mechanical, software, quality, regulatory, and industrial design) to deliver cohesive and integrated product solutions. Communicate effectively with team members and stakeholders to ensure clear alignment on project goals, trade-offs, and requirements. Regulatory Compliance Ensure electrical designs comply with applicable medical device regulations and standards (e.g., FDA, ISO 13485, IEC 60601, IEC 62304). Oversee the preparation and maintenance of design documentation required for regulatory submissions, audits, and approvals, in alignment with project plans and quality systems. Collaborate with quality and regulatory teams to integrate compliance considerations early in the design process. Innovation and Continuous Improvement Stay informed on industry trends, emerging technologies, and best practices in electrical engineering and medical device design and evaluate their applicability to company products. Lead continuous improvement initiatives that enhance product quality, reliability, manufacturability, and cost-effectiveness. Promote a culture of learning by participating in and encouraging professional development, training, and knowledge sharing across the engineering team. Technical Skills
Strong knowledge of analog, digital, RF, and power subsystem design, with demonstrated ability to integrate diverse technologies into cohesive systems. Proficiency in FPGA system architecture, including partitioning functions between hardware and software, resource optimization, and high-speed interface design. Experience defining and managing board-level and system-level interfaces, including documentation of specifications and design constraints. Ability to apply structured trade-off methodologies (e.g., performance vs. cost, power vs. thermal, reliability vs. complexity) in complex system designs. Design Proficiency with PCB design and CAD tools (e.g., Altium Designer) for schematic capture and layout. Strong understanding of circuit simulation and analysis methods for signal integrity, power distribution, and reliability. Expertise in both analog and digital circuit design, including mixed-signal systems. Familiarity with design practices for high-speed, low-noise, and safety-critical medical electronics. Testing and Validation Hands‑on experience with electrical test equipment (oscilloscopes, logic analyzers, spectrum analyzers, network analyzers, etc.) for prototype bring‑up and troubleshooting. Knowledge of EMC/EMI, safety, and performance testing methods relevant to medical devices. Familiarity with test fixture design, prototype assembly methods, and lab‑based validation workflows. Strong debugging and root‑cause analysis skills in both hardware and system‑level contexts. Leadership Strong communication and collaboration skills for effective cross‑functional teamwork in multidisciplinary product development. Experience leading and participating in design reviews, with the ability to evaluate electrical designs in the context of system‑level requirements. Demonstrated ability to mentor engineers, provide constructive feedback, and foster professional growth. Proven track record of technical project leadership, including planning, prioritization, and balancing competing requirements. Regulatory Awareness Familiarity with medical device regulations and standards, including FDA QSR, ISO 13485, IEC 60601, and IEC 62304. Experience generating and maintaining design documentation (e.g., design history files, risk analyses, traceability matrices) to support regulatory submissions. Understanding of design controls and quality system requirements in regulated environments. Innovation and Continuous Improvement Ability to evaluate and adopt new technologies, tools, and methodologies for improved product development. Experience applying structured continuous improvement methods (e.g., Lean, Six Sigma, root‑cause analysis) in engineering environments. Commitment to ongoing professional growth and staying current with advances in medical device technology and electrical engineering. Qualifications
Required Bachelor’s degree in Electrical Engineering, Biomedical Engineering, or related field. 8+ years of experience in electrical engineering with significant experience in medical device or other regulated product development. Proven record of leading system designs from concept through production release. Strong problem‑solving skills, attention to detail, and commitment to design excellence. Effective communicator with the ability to collaborate across functions and present technical concepts clearly. Demonstrated ability to manage multiple projects and priorities in a fast‑paced environment. Preferred Master’s Degree in Electrical Engineering, Biomedical Engineering, or related field. Advanced expertise in FPGA system architecture and high‑speed digital design. Experience with RF and wireless communication protocols (e.g., Bluetooth, Wi‑Fi). Familiarity with Lean, Six Sigma, or other structured continuous improvement methods. Prior experience with regulatory submissions and design controls in medical device development. Experience mentoring and developing engineering teams. DFx, V&V, and Regulatory Awareness
Design for X (DFx): Apply principles of manufacturability (DFM), assembly (DFA), test (DFT), reliability (DFR), and cost (DFC) to create robust, efficient, and scalable product designs. Verification and Validation: Lead V&V activities for electrical and system designs, including simulation, test planning, execution, and analysis of results to confirm compliance with requirements. Regulatory Alignment: Collaborate with quality and regulatory teams to ensure designs meet medical device standards and regulations such as FDA QSR, ISO 13485, IEC 60601, and IEC 62304. Documentation: Develop and maintain design documentation, including design history files, risk analyses, and traceability matrices, to support regulatory submissions and audits. Strategic Thinking: Ability to balance technical depth with broader business and product considerations. Decision‑Making: Skilled at making informed trade‑offs under ambiguity and guiding teams toward consensus. Mentorship: Commitment to developing junior engineers and fostering a culture of technical excellence. Collaboration: Effective at building trust and working across disciplines to align priorities and deliver results. Project Prioritization: Effectively manages multiple projects at once, balancing competing requirements while maintaining technical rigor and meeting deadlines. Accountability: Takes ownership of outcomes and sets high standards for quality, safety, and compliance. Culture
At Ensera Design, we specialize in medical device design and innovation, delivering solutions that improve patient outcomes. We are a mission‑driven team with a vision to be the partner of choice for healthcare pioneers seeking fresh thinking and innovative end‑to‑end solutions delivered at pace. Our mission is to enable healthcare to move forward with fast, flexible, and responsive design and manufacturing services that simplify complex challenges for pharmaceutical and medical device clients. We value creativity, collaboration, and accountability, with a strong emphasis on engineering rigor and attention to detail. As part of our team, you will be encouraged to pursue innovation, continuous improvement, and professional growth, while contributing to a culture that is both supportive and high performing. We’re seeking talented individuals, creative thinkers and problem solvers to collaborate with some of the world’s leading healthcare brands
If you want to be part of a contract design and manufacturing organization that thinks outside the box, or you’re passionate about advancing healthcare solutions, we’d love to hear from you.
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Systems Architecture and Integration Define and lead system-level electrical architecture, including analog, digital, RF, power, and FPGA subsystems, ensuring robust integration across hardware, firmware, and mechanical domains. Perform trade-off analyses (performance, cost, power, reliability) and guide architectural decisions to meet product and regulatory requirements. Establish and maintain clear interface definitions and provide technical leadership in design reviews to ensure scalable and manufacturable solutions. Electrical Design and Development Lead the design, development, and testing of electrical systems and components for medical devices. Oversee schematic capture, PCB layout, and circuit analysis to ensure robust and manufacturable designs. Direct simulation and evaluation activities to verify design integrity, performance, and compliance with requirements. Prototyping and Testing Lead the creation and evaluation of prototypes and test fixtures to verify design specifications and functional requirements. Oversee electrical and system-level testing, including EMC/EMI, safety, and performance testing, ensuring results feed back into the design process. Interpret and analyze test data, driving design changes and guiding the team toward robust, compliant solutions. Leadership and Collaboration Provide technical leadership in project planning, architecture decisions, and design reviews, ensuring alignment with product requirements and business objectives. Mentor and guide junior engineers, fostering technical growth and a culture of quality and accountability. Work closely with cross-functional teams (mechanical, software, quality, regulatory, and industrial design) to deliver cohesive and integrated product solutions. Communicate effectively with team members and stakeholders to ensure clear alignment on project goals, trade-offs, and requirements. Regulatory Compliance Ensure electrical designs comply with applicable medical device regulations and standards (e.g., FDA, ISO 13485, IEC 60601, IEC 62304). Oversee the preparation and maintenance of design documentation required for regulatory submissions, audits, and approvals, in alignment with project plans and quality systems. Collaborate with quality and regulatory teams to integrate compliance considerations early in the design process. Innovation and Continuous Improvement Stay informed on industry trends, emerging technologies, and best practices in electrical engineering and medical device design and evaluate their applicability to company products. Lead continuous improvement initiatives that enhance product quality, reliability, manufacturability, and cost-effectiveness. Promote a culture of learning by participating in and encouraging professional development, training, and knowledge sharing across the engineering team. Technical Skills
Strong knowledge of analog, digital, RF, and power subsystem design, with demonstrated ability to integrate diverse technologies into cohesive systems. Proficiency in FPGA system architecture, including partitioning functions between hardware and software, resource optimization, and high-speed interface design. Experience defining and managing board-level and system-level interfaces, including documentation of specifications and design constraints. Ability to apply structured trade-off methodologies (e.g., performance vs. cost, power vs. thermal, reliability vs. complexity) in complex system designs. Design Proficiency with PCB design and CAD tools (e.g., Altium Designer) for schematic capture and layout. Strong understanding of circuit simulation and analysis methods for signal integrity, power distribution, and reliability. Expertise in both analog and digital circuit design, including mixed-signal systems. Familiarity with design practices for high-speed, low-noise, and safety-critical medical electronics. Testing and Validation Hands‑on experience with electrical test equipment (oscilloscopes, logic analyzers, spectrum analyzers, network analyzers, etc.) for prototype bring‑up and troubleshooting. Knowledge of EMC/EMI, safety, and performance testing methods relevant to medical devices. Familiarity with test fixture design, prototype assembly methods, and lab‑based validation workflows. Strong debugging and root‑cause analysis skills in both hardware and system‑level contexts. Leadership Strong communication and collaboration skills for effective cross‑functional teamwork in multidisciplinary product development. Experience leading and participating in design reviews, with the ability to evaluate electrical designs in the context of system‑level requirements. Demonstrated ability to mentor engineers, provide constructive feedback, and foster professional growth. Proven track record of technical project leadership, including planning, prioritization, and balancing competing requirements. Regulatory Awareness Familiarity with medical device regulations and standards, including FDA QSR, ISO 13485, IEC 60601, and IEC 62304. Experience generating and maintaining design documentation (e.g., design history files, risk analyses, traceability matrices) to support regulatory submissions. Understanding of design controls and quality system requirements in regulated environments. Innovation and Continuous Improvement Ability to evaluate and adopt new technologies, tools, and methodologies for improved product development. Experience applying structured continuous improvement methods (e.g., Lean, Six Sigma, root‑cause analysis) in engineering environments. Commitment to ongoing professional growth and staying current with advances in medical device technology and electrical engineering. Qualifications
Required Bachelor’s degree in Electrical Engineering, Biomedical Engineering, or related field. 8+ years of experience in electrical engineering with significant experience in medical device or other regulated product development. Proven record of leading system designs from concept through production release. Strong problem‑solving skills, attention to detail, and commitment to design excellence. Effective communicator with the ability to collaborate across functions and present technical concepts clearly. Demonstrated ability to manage multiple projects and priorities in a fast‑paced environment. Preferred Master’s Degree in Electrical Engineering, Biomedical Engineering, or related field. Advanced expertise in FPGA system architecture and high‑speed digital design. Experience with RF and wireless communication protocols (e.g., Bluetooth, Wi‑Fi). Familiarity with Lean, Six Sigma, or other structured continuous improvement methods. Prior experience with regulatory submissions and design controls in medical device development. Experience mentoring and developing engineering teams. DFx, V&V, and Regulatory Awareness
Design for X (DFx): Apply principles of manufacturability (DFM), assembly (DFA), test (DFT), reliability (DFR), and cost (DFC) to create robust, efficient, and scalable product designs. Verification and Validation: Lead V&V activities for electrical and system designs, including simulation, test planning, execution, and analysis of results to confirm compliance with requirements. Regulatory Alignment: Collaborate with quality and regulatory teams to ensure designs meet medical device standards and regulations such as FDA QSR, ISO 13485, IEC 60601, and IEC 62304. Documentation: Develop and maintain design documentation, including design history files, risk analyses, and traceability matrices, to support regulatory submissions and audits. Strategic Thinking: Ability to balance technical depth with broader business and product considerations. Decision‑Making: Skilled at making informed trade‑offs under ambiguity and guiding teams toward consensus. Mentorship: Commitment to developing junior engineers and fostering a culture of technical excellence. Collaboration: Effective at building trust and working across disciplines to align priorities and deliver results. Project Prioritization: Effectively manages multiple projects at once, balancing competing requirements while maintaining technical rigor and meeting deadlines. Accountability: Takes ownership of outcomes and sets high standards for quality, safety, and compliance. Culture
At Ensera Design, we specialize in medical device design and innovation, delivering solutions that improve patient outcomes. We are a mission‑driven team with a vision to be the partner of choice for healthcare pioneers seeking fresh thinking and innovative end‑to‑end solutions delivered at pace. Our mission is to enable healthcare to move forward with fast, flexible, and responsive design and manufacturing services that simplify complex challenges for pharmaceutical and medical device clients. We value creativity, collaboration, and accountability, with a strong emphasis on engineering rigor and attention to detail. As part of our team, you will be encouraged to pursue innovation, continuous improvement, and professional growth, while contributing to a culture that is both supportive and high performing. We’re seeking talented individuals, creative thinkers and problem solvers to collaborate with some of the world’s leading healthcare brands
If you want to be part of a contract design and manufacturing organization that thinks outside the box, or you’re passionate about advancing healthcare solutions, we’d love to hear from you.
#J-18808-Ljbffr