Product Engineer

OrganOx is a commercial stage organ technology company dedicated to developing technologies to improve outcomes for patients with acute or chronic organ failure. The company was established as a spin out of the University of Oxford in 2008 and is now part of the Terumo Group. OrganOx is a pioneer in normothermic machine perfusion (NMP). It's flagship platform, the metra®, is available for use in the U.S., Europe, Canada, and Australia. It has been utilized in over 7,000 liver transplants to date to keep donor livers in a metabolically active state outside the body enabling longer preservation times and functional assessment of the organ prior to transplant, leading to an increased number of organs available for transplant. Founded in 1921, Terumo Corporation (TSE:4543) strives to fulfill its mission of “Contributing to Society through Healthcare” by providing a comprehensive range of solutions in the fields of therapeutic procedures, hospital operations, and life sciences in more than 160 countries and regions.

The position of R&D Product Engineer is responsible for engineering changes that affect the full life cycle of the metra , with specific focus on requirements and design history file management. This includes authoring requirements specifications, authoring test plans and executing testing, technical review of past performance and field experience, as well as supplier and manufacturing related upgrades, and feature enhancements This position will be located in the OrganOx US office located in Madison NJ.

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

· Lead assessment and authoring of design history file deliverables for organ perfusion platform including requirements, test specifications and verification.

· 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

This role will report directly to the SVP of Product Engineering and partner with other Product Engineering team in Madison NJ and Oxford UK.

Listed below are the major responsibilities of the role and a brief description of some of the key tasks to be performed. This list is not totally inclusive, and the person will be expected to complete tasks reasonably requested by the SVP of Product Engineering.

Major

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

· Review design history file deliverables and records and identify opportunities for improvement

· Writing and maintaining engineering documentation, including product specifications including flow down from user needs to system subsystem and module level and other device history file deliverables.

· 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.

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

· Risk Management: Identify and mitigate potential 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

Required

• Bachelor’s Degree in Engineering (such as Biomedical, Electrical, Systems or Software)
• 3+ years of work experience in design/new product development
• Experience with DHF maintenance/deliverable authorship
• Drafting and reviewing system requirements from user needs through subsystems and module level
• Experience with specification and test of electromechanical systems
  
  
  
  

Preferred

• Medical device industry experience
• Previous experience in medical devices under ISO 13485 QMS
• Supplier management including component obsolescence management
• Experience as CAPA owner

Benefits

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.