Senior Manager, Supplier Engineering – NPI
Diabetes Youth Families
Assembly
Salary
💰 $105,000 - $115,000 per year
Job Level
Junior
About the role
- Lead root-cause investigations in response to customer complaints
- 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
- Analyze and trend on product performance data to provide recommendations for product improvements
- Raise Supplier Corrective Action Reports (SCARs) in response to product performance trends and support timely closure of SCARs
- Work cross-functionally with other engineering teams and contracted suppliers to implement changes in manufacturing and inspection procedures
- Maintain good working relationships with suppliers to support root cause investigation and failure mitigation efforts
- 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 OrganOx’s Code of Conduct and company policies
- Collaborate with Product Sustaining Engineering and Contracted Suppliers to set quality control and management processes including sterilization, microbiology, supplier management, and contract manufacturing processes
Requirements
- Experience investigating and resolving SCARS and CAPAs
- 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
- 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
- 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
- Experience in driving a global quality mindset across teams and geographies
- Demonstrated strong attention to detail and “do it right the first time” attitude
- Bachelor’s degree in an Engineering discipline (Electrical, Mechanical, Bio-Medical, etc.) or the equivalent work experience
- 1-4 years of related hands-on engineering experience in Medical Devices, Pharmaceuticals or other regulated industry
- Excellent technical report writing skills
- Strong Root Cause Analysis, Design of Experiments, and Test Method Development experience as related to complaint investigations
- Strong experience with MS Office Products (Word, Excel, Visio, Project, PowerPoint, Outlook, etc.)
- Prior experience performing complaint investigations preferred
- A solid understanding of the FDA QSR Quality System Requirements preferred
- Knowledge of electro-mechanical troubleshooting techniques preferred
- Familiarity with ISO14971 and associated Risk Management Processes is a plus
- Six Sigma Green Belt or Black Belt Certification preferred
- Ability to travel 10-20% (domestically and internationally)
