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Electrical Engineering Manager

1 month ago

Orange, California, United States Veranex Full time
About This Role

Veranex is a leading service provider for medtech companies, offering a global team of experts to help clients anticipate challenges and find solutions throughout the development and commercial lifecycle. Our team accelerates new technologies to market and improves patient outcomes.

Key Responsibilities
  • Direct and lead internal resources and manage external development partners.
  • Lead electrical engineering projects through all phases of the medical product development process.
  • Ensure compliance with medical device regulations and standards per Veranex QMS.
  • Manage and develop the team to ensure performance meets and/or exceeds business and personal goals and objectives.
  • Provide leadership, training, guidance, and support to electrical engineering staff.
  • Participate in business development activities by reviewing proposal content and attending sales calls.
  • Provide input into functional strategy developed across sites.
  • Execute functional strategy within their team.
  • Manage and report on metrics that measure the impact of their functional group on the larger organization.
  • Work with peers in the organization to identify and execute on improvements to capabilities within their purview.
Qualifications
  • Bachelor's degree in electrical engineering and 8+ years of related experience; 1-2 years in a leadership capacity.
  • Expertise in one or more of the following applications:
    • Development of Low Power Embedded Systems and Products.
    • Embedded Systems Programming.
    • Robotics or motion control systems.
    • Systems including Microfluidics, disposable cartridge design, fluid or pneumatics systems.
    • Thermal control systems (TEC, resistive, PID control).
    • Optical detection.
    • Energy delivery (e.g. RF, laser).
    • Drug delivery.
    • Medical device sensor technologies.
    • Battery powered devices, wearables, IoT, home healthcare devices.
    • Wireless technologies (BLE, WiFi, LTE, NFC).
    • EMC design practices.
    • Knowledge of Machine Learning and its applications to embedded systems.
  • A broad range of electrical engineering experience, including expertise in one or more of the following areas:
    • PCB Schematic and Layout (Altium preferred).
    • Analog and digital design (MCU/MPU, FPGA based development).
    • Simulation tools (circuit level - Spice and simulation level - Python, COMSOL, Matlab).
    • Rapid prototyping, test, bring-up, and test automation.
    • Board level BOM management.
    • Design for Manufacturing and Assembly (DFM and DFT).
    • Design for adherence to standards (IEC, IEC 61010, IEC, IEC 14971).
    • Embedded hardware development (32/64 bit ARM-based uC, SOM, SBC, and understanding various OS and RTOS).
    • Best practice algorithms and sampling for closed loop systems.
  • Ability to work within and influence a multidisciplinary project team.
  • Excellent verbal and written communication skills, business acumen, and assertive decision-making ability.
  • Experience with new product design and development.
  • Familiarity with risk management activities (e.g. FMEAs).
  • Knowledge of FDA QSR Regulations (21 CFR 820), ISO 13485:2003 (Quality System) and ISO 14971:2007 (Risk Management).
  • Knowledge with medical device, diagnostic, and EMC standards is desired.
Preferred Qualifications
  • Experience in medical devices consulting.
  • Fluency with Altium Designer.
  • Development of low power embedded systems.
  • Specific experience in development of medical device and/or diagnostic products highly preferred.
  • Familiarity with requirements development, embedded system architecture design, and other system engineering activities.
  • Familiarity with test method development, quantitative analysis (simulated and empirical), and basic statistics.
  • Familiarity with requirements analysis is a plus; translating stakeholder needs (e.g. Customer, User) needs into functional design inputs and output documents, and contributing to design V&V traceability matrice.
About Veranex

Veranex is an equal opportunity employer and prohibits discrimination of any kind. All qualified applicants will receive consideration for employment without regard for race, color, religion or belief, sex (including pregnancy, gender identity or gender expression), sexual orientation, parental or marital status, disability, age, status as a protected veteran, national, social, or ethnic origin, or any other applicable legally protected characteristics.