Responsible for establishing, evaluating, and improving processes for the production of 3-D generated coronary models.

Job Responsibilities:

• Establish reliable processes; develop manufacturing processes and quality work instructions.
• Plan, lead, execute and complete projects to improve quality and efficiency.
• Design and execute prototype/process development testing early in the product design lifecycle to provide feedback on design and ensure successful final validation/transition of product into commercial.
• Perform process and test method validation, develop/support protocols (IQ/OQ/PQ), perform analysis of results and write reports. 
• Generate/develop process FMEAs.
• Extract and analyze data to measure quality and process performance and provide solutions for improvements.
• Follow all Good Manufacturing Practices (GMP’s), policies and Standard Operating Procedures (SOP’s) to ensure that FDA regulations are met.
• Investigate and resolve production issues, non-conformances, CAPAs and complaints.
• Establish process and quality monitoring and evaluate data to ensure process is in control.
• Help develop training materials for new processes.
• Requires a working knowledge of lean manufacturing concepts such as optimizing flow of product/process, value stream mapping and waste elimination. 

Required Skills :

• Strong statistical and data analysis skills.
• Lean manufacturing knowledge.
• 3 years experience in Medical Device. 
• Advanced skills in Microsoft Word, Excel, PowerPoint, and Minitab (or other statistical analysis software).
• Must understand QSR regulations 21 CFR Part 820, MDD Annex II and ISO 13485 and 14971
• Ability to write reports and effectively present information to all audiences, including management, and government or regulatory agencies.
• Demonstrated ability to learn quickly and work in cross-functional teams.
• Strong communication and documentation skills.
• Creative capacity for improving processes and finding solutions.
• Programming skills such as Python and/or R preferred

Educational Requirements & Work Experience: 

• BS or MS in Biomedical, Industrial, Mechanical Engineering or other Scientific or Technical field.
• Minimum 3 years of experience in cGMP manufacturing particularly medical device

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