Job Description
To Make an Impact, You Will:
Lead and contribute to the design, debug, and characterization of high-voltage, mixed-signal circuits within complex Class II/III medical devices.
Provide both technical direction and hands-on guidance in system architecture, high-voltage isolation strategies, analog/digital circuit design, power delivery, and safety-critical subsystems.
Lead and coordinate lab activities, including board bring-up, troubleshooting, and advanced system debugging using oscilloscopes, HV probes, and other specialized test equipment.
Oversee and contribute to the preparation, execution, and review of design verification and validation protocols, characterization reports, and risk management activities and documentation (FMEAs, hazard analyses, trace matrices).
Manage sustaining engineering activities, including leading root cause investigations, directly contributing as needed with troubleshooting of production assemblies and field returns, and implementing design updates to improve reliability and maintain compliance.
Collaborate cross-functionally with Systems, Mechanical, Software, Manufacturing, Quality, and Regulatory teams to ensure effective design transfer, manufacturing scale-up, and long-term support of released products.
Ensure robust design control and documentation practices, including authorship and critical review of product requirements, specifications, verification reports, and design history file elements.
Maintain full ownership of design documentation, including user driven product requirements, detailed product specifications, characterization and verification reports, and traceability matrices.
Serve as a technical point of escalation for field issues, providing both leadership and hands-on support during investigations and corrective action activities.
Lead and contribute to technical design reviews, internal audits, and regulatory inspections as a subject matter expert in high-voltage electrical design.
Actively foster a culture of innovation, accountability, and continuous improvement, setting the standard by working alongside the team in both technical and organizational capacities.
Recommend and implement process improvements to increase team productivity, product quality, and development efficiency.
Ensure compliance with FDA regulations, ISO 13485, IEC 60601, EMC/EMI design and compliance testing, and company policies, while maintaining positive and cooperative communication across all levels of the organization.
Recruit, hire and maintain a high-performing team to drive and achieve Company goals.
May perform other duties as assigned.
We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com.To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.
Skills and Requirements
Bachelor's degree in Electrical Engineering or related field required. Master's degree preferred.
8+ years' experience in electrical engineering with direct experience in high-voltage medical device design.
4+ years' experience in leadership or management roles.
Experience delivering Class II/III FDA-regulated products.
Demonstrated leadership skills with the ability to mentor, motivate, and develop high-performing engineering teams.
Strong technical problem-solving ability to support both new product development and sustaining engineering activities.
Proficient in reading, interpreting, and reviewing circuit schematics and PCB layouts; desired experience with Altium (preferred), Allegro, or OrCAD Cadence.
Hands-on experience with board bring-up, lab-based debugging, and characterization of high-voltage systems.
Proficient with common lab equipment including oscilloscopes, high-voltage probes, network analyzers, SMU's, power supplies, and precision DMMs.
Solid knowledge of high-voltage safety, creepage/clearance, insulation, CTI, and EMI/EMC design and compliance testing.
Familiarity with electro-mechanical integration including harness design, connectors, and HV assemblies.
Exposure to scripting or programming for hardware test automation; familiarity with Python or similar languages preferred.
Strong working knowledge of medical device design controls, risk management (ISO 14971), and regulatory standards (IEC 60601-1, ISO 13485).
Proficient knowledge and skill in Microsoft Office Suite applications and requirements management tools (e.g., Aligned Elements preferred, but exposure to DOORS, Jama, etc.).
Excellent verbal and written communication skills with ability to effectively communicate at multiple levels of the organization, including executives, regulatory bodies, and cross-functional teams.
Ability to manage multiple priorities, delegate effectively, and meet deadlines in a fast-paced, dynamic environment.
Strong organizational and follow-up skills with attention to detail and compliance.
Self-motivated with the ability to work independently, exercise sound judgment, and take initiative in both short- and long-range planning.
Ability to foster cross-functional collaboration, build consensus, and drive results.
Ability to travel up to 10% of the time; overnight and/or international travel may be required.
Ability to lift 10-15 pounds.
