Make an impact through innovation that is shaping the future of healthcare. We are focused on creating better ways of developing and delivering life-improving therapeutics. We are seeking a dynamic and dedicated individual with motivation and skills to contribute and help advance our mission.
As a key member of our Device Development team, the Principal Electrical Engineer is responsible for leading and performing in design, development, modification, and evaluation/acceptance of printed circuit boards, components, and integrated circuitry for medical devices, test fixtures, and other hardware solutions.
The successful Electrical Engineer has strong engineering, scientific, quality, and regulatory experience in full development lifecycle for class II or III medical devices. Determines design approaches and parameters. Analyzes and specifies equipment to establish operating data, conduct experimental tests and evaluate and report results. Selects components and equipment based on analysis of specifications and reliability. Leads and performs in pre-concept through architecture definition, development, verification, transfer, and product manufacturing while adhering to Quality Management processes. Experience in bringing new PCB designs to realization, IEC 60601-1-2 pre-scan and certification activities including IEC safety standards. Works well individually and with team of non-technical members and technical team of software, electronics, and mechanical engineers in dynamic development of novel medical devices.
What you will be doing:
- Responsible for hardware development from pre-concept to production for compact medical devices.
- Independently responsible for all stages of electrical hardware design and development for complex products, solutions, and platforms, including design, validation, tooling, manufacturing, and testing.
- Creates detailed electrical design package (including specifications, BOMs, schematics, wiring diagrams, analyses, etc.) to support design reviews, testing, certifications, and production.
- Reviews and evaluates designs and project activities for compliance with technology and development guidelines and standards to improve product quality.
- Evaluates and proposes modelling and testing methodologies to validate component, circuit, and hardware designs and thermal/emissions management. Medical device design, development, verification, and validation to FDA major level of concern.
- Works on complex issues where analysis of situation or data requires an in-depth evaluation of variable factors.
- Collaborates with Quality team to ensure procedures and methods to ensure quality standards are met and maintained throughout the development cycle.
- Oversees and collaborates in development from external contract development organizations.
- Manages creation and deployment of software driven manufacturing and test tools at contract manufacturing organizations.
- Collaborates with internal and external engineers on PCB design, hardware functionality, architecture, and development.
- Direct contribution to all device history, risk mitigation, and quality documents for the devices required for regulatory filings (i.e., 510k, De Novo 510K and PMA).
- Assists in selection and performance in vendor management activities when required.
- Performs other duties as they are identified to support cross-functional teams.
What you will need:
- Experienced in design-for-test (DFT) and design-for-manufacturing (DFM) practices for high-volume products.
- Minimum BS in EE, CE, CSE
- 10 years’ experience in full-cycle, medical device development, preferably in drug/device combination products, Class II/III electromechanical devices.
- Extensive experience in commercializing devices from pre-concept to production.
- Good project management skills.
- Working knowledge of Medical Device Development Life Cycle and Manufacturing.
- Design Controls and experience with FDA QSR 21 CFR Part 820 and ISO 13485.
- Minimum 5 years’ electronics design, PCBA test, bring-up, and end product deployment using Altium Designer
- Experience working with 32bit Cortex-M microcontrollers for medical device embedded applications.
- Understanding of I2C, SPI, UART and other communication protocols.
- Strong familiarity with LT Splice and Tina TI Solid working knowledge of analog, digital, and mixed-signal design principles, and practices.
- Schematic capture, board layout, ESD/EMI immunity.
- Experience with documentation control (ECO, rework instructions, etc).
- Familiarity with low power systems, battery performance testing and power consumption.
- Recognized for being well organized and self-directed with strong interpersonal skills and with an ability to communicate to people at all levels of the organization and lead with influence.
- Proactive, forward-thinking, and creative with high ethical standards and a team player with leadership skills and ability to influence others to achieve successful outcomes and meet timelines.
- Familiarity with domestic and international regulations and industrial guidance documents (e.g., IEC 60601, ISO, FDA guidance and CE Mark requirements).
- Energetic individual with can-do attitude and demonstrated team player.
- Ability to handle multiple project and priorities with exceptional organizational and time management skills.
- Ability to function efficiently, effectively, and at times independently in a fast-paced, changing environment.
- Strong team player aligned with our values.