Senior Electronics Product Engineer (R&D)

ABOUT ORGANOX:

OrganOx is an innovative, fast-paced, global medical device company with a mission to save lives by making every donated organ count. We are a commercial stage organ technology company, spun out of the University of Oxford in 2008, committed to improving transplantation outcomes throughout the world. The company’s first product, the OrganOx metra ® normothermic machine perfusion (NMP) system for liver transplantation, has been used to support more than 5,000 liver transplant operations globally.

Position Summary

The position of Sr R&D Product Electronics Engineer is responsible for engineering changes that affect the full life cycle of the metra . This includes responding to performance in the field, supplier and manufacturing related upgrades, and feature enhancements. This role will report directly to the SVP of Product Engineering and partner with other Product Engineering team in Madison NJ and Oxford UK.

This is a full time, in office role located at OrganOx’s US headquarters in Madison, NJ.

As part of a small multi-disciplinary Product Engineering team, the successful incumbent will support design activities in the following areas:

· Lead root cause analyses of field performance issues, manage and qualify component and supplier migrations, lead design changes to support improved manufacturing yield or system performance, and new features and functionality requested by clinical customers. This will require close partnership with field-based customer service, operations and quality teams.

· Support development of testing protocols working in concert with suppliers to assess the quality of system and sub-system PCB .

· Working closely with the New Product Development and Operations teams throughout development projects with a focus on supporting design reviews and design transfer activities for next generation electronics.

Investigations into the root cause of failures will be conducted in a timely manner, in collaboration with Quality and Product Support (Servicing) departments as well as applicable suppliers and reported using the OrganOx investigations processes.

Major Responsibilities

Under direction from the SVP of Product Engineering, the Senior R&D Product Electronics Engineer will be responsible for:

· Investigating device issues which appear to be electrical in origin, determining and reporting the root cause (in collaboration with the quality, service and operations departments), and recommending corrective actions.

· Working on problems for production support, quality improvements, and line extensions.  This includes conducting and supporting problem solving efforts and root cause analysis, CAPA ownership, and identification and evaluation of potential solutions.

· Interpreting and understanding the product’s intended use, clinical procedures, customer needs and design inputs.

· Creating and/or refining engineering documentation, such as electrical schematics, PCB layout changes, product requirements, the Design History File and the Device Master Record.

· Verification and Validation Testing: Conduct thorough testing to verify that the electrical systems meet functional requirements and validate their performance against clinical needs including hardware and embedded systems (firmware) functionality.

· EMC Compliance: Ensure medical device designs comply with Electromagnetic Compatibility (EMC) regulations by conducting necessary testing and mitigation strategies.

· Risk Management: Identify and mitigate potential electrical safety risks throughout the design process through FMEA analysis and risk assessment.

· Regulatory Compliance: Adhere to relevant regulatory standards (e.g. IEC 60601-1, IEC 62368-1, or equivalent) for medical devices, including documentation and reporting requirements.

· Prepare visualizations and conclusions for presentation to upper management.

· Demonstrating ownership and integrity of work, a spirit of volunteerism, a passion for excellence and our products, and a hands-on approach to engineering.

Requirements

• Bachelor’s Degree or equivalent qualification/experience in electrical engineering, or other relevant engineering discipline along with 5-7+ years of work experience.
• Experience with communication protocols such as I2C, SPI, UART, RS-485, TCP/IP, Wi-Fi, Bluetooth, and BLE.
• Knowledge of Electrical engineering practices and design principles including schematics and PCB layout, functional design specifications, and testing.
• Experience with specification and test of embedded systems (firmware).
• Knowledge of design and concept generation, and engineering analysis utilizing CAD and CAE tools.
• Adhere to the letter and spirit of OrganOx’s Code of Conduct and all other company policies.
  
  

Preferred

• Experience in high reliability design requirements such as Medical Device or Aerospace.
• Previous experience in medical devices under ISO 13485 QMS.
• Supplier management including component obsolescence management.

#LI-Onsite

A job description does not imply that the duties stated are the only ones to be performed by the job holder. Job holder will be required to follow any other job-related instruction as reasonably requested by their line manager or their designate.

Benefits

The Pay Range for this position is $150,000 - $160,000 annually, with a 10% target annual bonus and benefits.

At OrganOx, we offer competitive compensation and comprehensive benefits available from day one, including health, dental, vision, disability coverage, and flexible spending accounts. Additionally, we offer a 401(k)-retirement plan with company matching after 90 days, paid time off, holidays, and additional leave benefits, as well as employee discounts and access to our onsite wellness facility. OrganOx supports work-life balance and provides opportunities for ongoing professional development.

We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity or expression, national origin, disability status, protected veteran status, genetic information, or any other characteristic protected by law.