About This Role:
Veranex has an exciting opportunity to join our team as a Principal Electrical Engineer. You will be part of a team working to improve lives globally through medical technology innovation. reporting to the Director of Electrical Engineering, the Principal Electrical Engineering role serves as a lead engineer on programs, providing technical leadership, oversight, targeted engineering execution, and support of business development activities.
What You Will Do
- Provides leadership to internal resources and manages external development partners.
- Leads electrical engineering projects through all phases of the medical product development process
- Ensures compliance with medical device regulations and standards per Veranex QMS
- Assists to develop the team to ensure performance meets and/or exceeds business and personal goals and objectives
- Provides leadership, training, guidance, and support to electrical engineering peers
- Provides feedback to management during the project quoting and project planning process OR Participates in business development activities by providing technical expertise for proposal content and sales calls
- Functions as electrical engineering lead on product development programs
- Manages and reports on metrics that measure the impact of their technical team on the larger organization
- Works with peers in the organization to identify and execute on improvements to capabilities within their purview.
Qualifications
Required skills:
- Bachelor's degree in electrical engineering or similar field and 5-8 years of related experience.
- Expertise in one or more of the following applications:
- Robotics or motion control systems
- 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
- Working knowledge of Embedded Programming Languages and Tools (C/C++, Python, BitBucket, etc)
- A broad range of electrical engineering experience, including expertise in one or more of the following areas:
- PCB Schematic and Layout (Altium Required, Cadence/Allegro in addition, a plus)
- Analog and digital design (MCU/MPU, FPGA based development)
- FPGA design Experience preferred
- 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 an dDFT)
- Design for adherence to standards (IEC 60601-1, IEC 61010, IEC 60601-1-2)
- Embedded hardware development (32/64 bit ARM-based uC, SOM, SBC, and understand of various OS.
- 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 (60601-1, 61010-1, 60601-1-2, 61326, and other relevant collateral and particular standards)
Preferred:
- 1-2 years of experience leading technical teams
- 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