Product Quality Engineer

Job Description

Job Description

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 Engineering team at OrganOx is a technical quality engineering team responsible for monitoring, understanding, and improving product performance of the OrganOx Metra, a Class III medical device. The Product Quality Engineering team works closely with Product Sustaining Engineering and Contracted Suppliers to set in place quality control and management processes for externally built products and componentry, including sterilization and microbiology, supplier management, and contract manufacturing processes.

The Product Quality Engineer position will be focused on hands on complaint investigation of returned product. This position is ideal for an entry-level engineer looking to grow and develop hands on quality engineering skills. The ideal candidate will have some prior laboratory or investigation experience, and showcase an ability to analyze product quality issues and work cross-functionally to solve problems related to product quality.

The successful candidate is 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 office.

Requirements

Major Responsibilities

Under direction from the Senior Product Quality Engineer and Senior Manager, Product Quality Engineering, the Product Quality Engineer may be responsible for the following:

• Support root-cause investigations in response to customer complaints
• Support hands-on analyses of returned products to identify root causes of failures
• Receive all returned products and perform full decontamination process in accordance with established procedures.
• Gather all relevant case details including service reports, system data, and clarifying information needed to support a thorough complaint evaluation with assistance from the Product Quality Engineer
• Execute hands on lab work such as monitoring running test circuits or preparing equipment for evaluation

· Support development of investigation criteria and test methods to properly diagnose and root cause field failures

• Raise Supplier Corrective Action Reports (SCARs) in response to product performance trends. Support timely closure of SCARs.
• Work cross-functionally with other engineering teams and contracted suppliers to implement changes in manufacturing and inspection procedures to mitigate field failures.

· Support CAPAs, Escalations, and engineering investigations in response to field quality issues.

• Participate in the development and review of engineering change orders that impact product quality activities
• 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.

Skills & Experience

• Familiarity with quality engineering principals such as complaint investigation, SCARS and CAPAs
• Experience in handling laboratory materials and conducting hands on lab investigations is a plus
• Excellent oral and written communication skills with the ability to communicate with audiences of varying technical skills
• Strong organizational skills with the ability to manage multiple tasks simultaneously
• A strong ability to prepare written technical plans and reports documenting failure investigations
• Proven ability to work cross functional and within global teams, fostering a culture of high collaboration
• Ability to be self-driven and solve complex problems independently. Committed to upholding OrganOx values in daily work and decision-making
• Experience in driving a global quality mindset across teams and geographies
• 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 is required

· 0-2 years of related hands-on engineering experience in Medical Devices, Pharmaceuticals or other regulated industry is required

• Excellent technical report writing skills are required
• Strong experience with MS Office Products (Word, Excel, Visio, Project, PowerPoint, Outlook, etc.) is required
• Prior experience performing complaint investigations preferred
• Ability to travel 10-20% (domestically and internationally)

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

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.