Manager, Electrical Engineering

$60,601 - $197,890/Yr

Veranex - Orange, CA

Full-time - Mid Level

Orange, CA

Miscellaneous Manufacturing

About the position

Veranex is the leading service provider for medtech companies, dedicated to improving lives globally through medical technology innovation. We are seeking a Manager of Electrical Engineering to join our team. In this role, you will provide technical leadership and oversight for the electrical engineering discipline, ensuring that our projects meet the highest standards of quality and compliance with medical device regulations. You will report directly to the Director of Electrical Engineering and will be responsible for managing a team of engineers, guiding them through the product development process, and supporting business development activities. As the electrical engineering lead, you will direct and lead internal resources while managing external development partners. You will oversee electrical engineering projects through all phases of the medical product development process, ensuring compliance with Veranex's Quality Management System (QMS). Your leadership will be crucial in developing your team to meet and exceed business and personal goals, providing training, guidance, and support to ensure high performance. In addition to managing your team, you will participate in business development activities, reviewing proposal content, and attending sales calls. You will also contribute to the functional strategy developed across sites and execute this strategy within your team. Reporting on metrics that measure the impact of your functional group on the larger organization will be a key responsibility, as will collaborating with peers to identify and implement improvements to capabilities within your purview.

Responsibilities

• Function as electrical engineering lead on product development programs
• 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.

Requirements

• Bachelor's degree in electrical engineering
• 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 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 60601-1, IEC 61010, IEC 60601-1-2, IEC 14971), Embedded hardware development (32/64 bit ARM-based uC, SOM, SBC, and understanding various OS and RTOS)
• 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 (60601-1, 61010-1, 60601-1-2, 61326, and other relevant collateral and particular standards)

Nice-to-haves

• 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 matrices.