Product Quality Engineer

ABOUT ORGANOX:

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.

Position Summary

The Product Quality Team at OrganOx is a technical quality engineering team responsible for monitoring, understanding, and improving product performance, in addition to owning quality processes within the service organization.

The Product Quality Engineer will be technical, hands-on, and customer focused with an ability to analyze, diagnose and test product quality issues. The successful candidate is accountable, collaborative, has excellent communication and problem solving skills, and is passionate about delivering world-class products that make healthcare more accessible, simpler, and safer.

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 exhaustive.

This is a flexible, on-site role in our Madison, NJ facility.

Requirements

Major Responsibilities

Under direction from the Senior Product Quality Engineer, the Product Quality Engineer will:

· Conduct hands-on analyses of returned products to identify root causes of failures

· Develop investigation criteria and test methods to properly diagnose and root cause field failures

· Analyze and trend on product performance data to provide recommendations for product improvements

· Perform Quality trending of Service data and conduct investigations to identify causes of Servicing and Service-related complaint trends, including issues in Servicing workmanship and Out of Box failures.

· Review the output of Servicing and related Complaint or Non-Conformance Investigation activities to ensure that the resulting work complies with all regulatory and service requirements, as well as facility, divisional, and corporate objectives for defect prevention and continuous improvement.

· Audit and review Complaint Investigations and records of Servicing activities to ensure they are thorough, accurate, self-explanatory, and completed in a timely manner into the complaint handling system.

· Analyze service-related PFMEAs and other activities to support pre-market and post-market risk management activities

· Provide ongoing training to Service staff on regulatory requirements associated with complaint investigations and Servicing records

· Foster supplier relationships and support Supplier corrective action requests

· Support Product Transfer teams by aligning on quality requirements and processes for new or transferred products

· Plan, develop, and conduct Service Manual and Service work instruction validations (IQ, OQ, PQ), test method validations, and inspection method validations

· Participate in the development and review of engineering change orders that impact servicing activities

· Work with Engineering to design and implement tooling and fixturing required to perform servicing activities and implement error-proofing (Poke-Yoke) in those stations

· Work cross-functionally to support implementation of changes in servicing and inspection procedures to mitigate field failures.

· Support CAPAs, Escalations, DCNs, and other engineering projects to address and resolve field quality issues, ensuring timely implementation and compliance with quality standards

· Perform DHR, Service History record, and PFMEA reviews in support of complaint investigations

· Adhere to the letter and spirit of OrganOx’s Code of Conduct and all other company policies.

While the above key responsibilities are the main elements of the titled job the Vice President Quality may at times request other tasks deemed to be within their capabilities.

Skills and Experience

· Excellent technical report writing skills

· Strong Root Cause Analysis, Design Of Experiments, and test method development experience as related to Service activities and complaint or non-conformance investigations

· Experience in leading investigations and trending analysis, leveraging expertise in troubleshooting electro-mechanical systems and engineering custom test fixtures and apparatuses for functional and performance validation

· Ability to manage multiple investigations and projects independently.

· A solid understanding of the FDA QSR Quality System Requirements, and the ability to apply the knowledge to comply with goals and objectives.

· Strong experience with MS Office Products (Word, Excel, Visio, Project, PowerPoint, Outlook, etc.)

· Strong experience with statistical analysis of data. Experience with Minitab preferred. Experience with Six Sigma principles preferred.

· Excellent oral and written communication skills with the ability to communicate with audiences of varying technical skills

· A strong ability to prepare written technical plans and reports in support of engineering changes, product or process validations, and failure investigations.

· Strong focus on meeting customer needs.

· Ability to work with cross-functional teams.

· Ability to be self-driven and solve complex problems independently.

· Demonstrated strong attention to detail and “do it right the first time” attitude

Qualifications

· Bachelor’s degree in an Engineering discipline (Electrical, Mechanical, Bio-Medical, etc.) or the equivalent work experience

· 3-7 years of related hands-on engineering experience in the medical device industry, or equivalent.

· Ability to travel 10-20%

· Strong background in troubleshooting electro-mechanical systems and interpreting electrical schematics and circuit diagrams

· Experience using diagnostic tools such as digital multimeters and oscilloscopes, as well as developing and validating test methods for components including PCBs, motors, pumps, power supplies, and batteries

· Prior experience in implementing new processes and driving improvements.

· Experience in a customer focused Service organization is a plus

· Familiarity with ISO14971 and associated Risk Management Processes is a plus

· Knowledge of and/or experience with product decontamination and Blood Borne Pathogen exposure controls is a plus

· Experience in an FDA regulated environment is a plus

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

At OrganOx, we value innovation, evidence, integrity, teamwork, respect, and passion. We offer competitive compensation and comprehensive benefits, including healthcare and retirement plans. We support work-life balance and provide 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.