Principal Electrical/System Engineer

Essential Job Duties

• Technical Ownership: Collaborate with Marketing, Software, and Clinical Engineering to define and refine product requirements across multiple programs within the Advanced Energy portfolio.
• Technical Strategy & Roadmap: Define the multi-year technology and architecture roadmap for energy-based surgical platforms, setting technical direction that spans multiple products and programs.
• System Integration: Identify and implement methods to satisfy product specs, ensuring seamless integration into effective system designs.
• Development & Testing: Develop, validate, and document hardware solutions that meet clinical and environmental requirements.
• Problem Solving: Provide technical expertise to resolve complex design, manufacturing, or field challenges.
• Prototyping: Guide prototyping and feasibility studies for future product concepts, directing engineers through build, test, and down-select decisions.
• Stakeholder Support: Offer expert guidance on energy-based surgical products to internal company stakeholders, including senior leadership and executive technical reviews.
• Organizational Influence: Represent Advanced Energy engineering in cross-divisional and executive-level technical reviews; influence platform, architecture, and make/buy decisions at a business-unit level.
• Quality & Regulatory: Define risk management strategy and process (DFMEA, hazard analysis, risk/benefit assessment per ISO 14971) and design verification/validation planning to ensure compliance with IEC 60601 series standards, and applicable FDA/international regulatory requirements. Author or review technical documentation supporting regulatory submissions (e.g., 510(k), CE/MDR technical files).
• Clinical Collaboration & Validation: Partner with Clinical Engineering, surgeons, and human factors teams to validate device performance against real-world surgical use cases, including support for cadaver labs, animal studies, or clinical evaluations as needed.
• Risk Management Leadership: Drive cross-functional risk analysis activities throughout the product lifecycle, identifying and mitigating electrical, mechanical, and use-related hazards for patient and user safety across the product portfolio.
• Mentorship & Technical Leadership: Formally mentor Staff and Senior engineers, lead cross-team design reviews, and drive technical communities of practice to raise engineering capability across the organization.

Required Skills and Experience

• Proficient in mixed signal design, embedded system design, and patient-isolated PCBA design.
• Skilled in component selection, lifecycle management, and design for reliability/manufacturability.
• Experienced in PCB fabrication, assembly, and testing.
• Hardware development in fast-paced, high-impact environments.
• Knowledgeable in all product development phases: design, implementation, debugging, verification, validation, and manufacturing transfer.
• Team player with hands-on engineering experience.
• Demonstrated application of medical electrical equipment standards (e.g., IEC 60601-1, IEC 60601-1-2 EMC, IEC 60601-2-2 for HF surgical equipment) in product design and verification.
• Strong communicator, able to influence and collaborate across teams and levels.
• Willingness to travel (~5-10%).
• Growth mindset; eager to learn and solve tough technical challenges.
• Passion for creating robust, reliable products.
• Hands-on experience with electrical safety design and testing for patient-connected circuitry.
• Direct experience with medical device design controls, including risk/hazard analysis, design verification and validation (V&V) planning and execution.
• Demonstrated technical leadership across multiple technical domains or product platforms, with the ability to influence architecture and strategy decisions org-wide without formal authority.
• Track record of successfully developing and launching multiple products or product generations through the full product development lifecycle.
• Project leadership or mentoring experience.

Required Education and Training

• Bachelor's degree (BSEE).
• 15+ years experience in related electrical engineering roles.
• 8+ years of hands-on medical device product development experience, including multiple products taken through design verification/validation and regulatory clearance or approval (FDA 510(k)/PMA or equivalent).

Preferred Skills and Experience

• Advanced degree (MSEE or PhD).
• Experienced with switched-mode power supplies and transformer/magnetic component design.
• Experienced with electrical safety, EMI/EMC testing and mitigation.
• Experienced with design control requirements for medical devices, such as risk/failure analysis, creation of product requirements, design verification and validation, and providing technical support for regulatory submissions.
• Experience with post-market surveillance activities, including complaint investigation, CAPA, and field failure root-cause analysis.
• Experience influencing product or technology strategy, including contributions to patents, publications, or industry standards bodies.