Overview
Product Quality Engineer - Disposable Set at OrganOx. OrganOx is a global medical device company focused on improving transplantation outcomes. 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 Product Quality Engineering team monitors, understands, and improves product performance of the OrganOx Metra (Class III medical device). The team collaborates with Product Sustaining Engineering and contracted suppliers to establish quality control and management processes for externally built products and components, including sterilization, microbiology, supplier management, and contract manufacturing processes. The Product Quality Engineer will analyze product quality issues, work cross-functionally to solve problems, and contribute to delivering world-class, safe, accessible healthcare.
Major Responsibilities
* Analyze and trend product performance data to provide recommendations for product improvements
* Raise Supplier Corrective Action Reports (SCARs) and Nonconforming Material Reports (NCs) in response to product performance trends
* Support root cause investigation and timely closure of SCARs and NCs
* Work cross-functionally with other engineering teams and contracted suppliers to implement changes in manufacturing and inspection procedures to mitigate field failures
* Maintain good working relationships with suppliers to support root cause investigation and failure mitigation efforts
* Support updates to supplier quality agreements
* Support validation of new processes at suppliers
* Support hands-on analyses of returned products to identify root causes of failures
* Support development of investigation criteria and test methods to properly diagnose and root cause field failures
* Provide technical insight to sterilization and microbiological processes
* Support CAPAs, escalations, and engineering investigations in response to product quality issues
* Participate in the development and review of engineering change orders that impact product quality activities
* Perform DHR, Service History records, and PFMEA reviews in support of complaint investigations
* Adhere to OrganOx's Code of Conduct and company policies
Requirements & Skills
* Demonstrable hands-on engineering experience in the medical device industry, or equivalent
* Knowledge of medical device sterilization and microbiology is preferred
* Excellent technical report writing skills
* Strong Root Cause Analysis, Design Of Experiments, and test method development experience related to complaint investigations
* Experience investigating and resolving SCARs and CAPAs
* Understanding of FDA QSR Quality System Requirements; ability to apply this knowledge to meet goals
* Strong experience with MS Office; proficiency in statistical analysis (Minitab preferred); Six Sigma knowledge is a plus
* Excellent oral and written communication skills across audiences of varying technical levels
* Ability to prepare written technical plans and reports in support of engineering changes, product/process validations, and failure investigations
* Customer-focused mindset and ability to work across global teams
* Self-driven, capable of solving complex problems, and upholding OrganOx values
* Experience driving a global quality mindset across teams and geographies
* Demonstrated 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 equivalent work experience
* Ability to travel 10-20%
* Familiarity with ISO 14971 and Risk Management is a plus
* Six Sigma Green Belt or Black Belt Certification preferred
Benefits
OrganOx offers competitive compensation and comprehensive benefits, including healthcare and retirement plans. We value innovation, evidence, integrity, teamwork, respect, and passion, supporting work-life balance and ongoing professional development. We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to age, disability, gender identity, pregnancy, race, religion or belief, sex, sexual orientation, or any other characteristics protected by law.
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