Senior Process Engineer

Our Company

Gentuity is an exciting and highly innovative medical technology firm, active in the research and development, clinical translation, and commercialization of vascular imaging devices. This opportunity provides the candidates the unique chance to work on innovative medical products, with the potential to significantly change the practice of medicine in the care of patients suffering from a wide range of highly debilitating vascular diseases.


• Design and develop manufacturing processes, tooling, and fixtures to meet business needs while enhancing process safety, quality, and productivity.
• Support all process validation activities (e.g., development and execution of IQ/OQ/PQ)
• Develop work instructions, workmanship standards and process documents, and ensure adequate training of production staff.
• Lead the root-case and corrective action response and countermeasure implementation for production issues, product defects, customer complaints, and any other technical challenge that may arise.
• Leading the design transfer process and ensuring all activities are being completed per the project plan and that all processes meet production-level PpKs
• Continuous improvement of existing development and manufacturing operations for increased quality, productivity, efficiency, and cost savings.
• Utilize tools like Gage R&R, Cp, Cpk, and SPC to improve the process and first-pass yield
• Monitor, measure, and report on manufacturing and quality metrics.
• Investigate production issues and generate nonconforming reports as required.
• Work with R&D and Quality teams to investigate production issues and implement solutions.
• Support prototype and pilot production of new products, product changes, and enhancements in coordination with R&D, Process and Quality Control functions.
• Manage and update as needed documentation required for product manufacturing.
• Monitor, measure, and report on manufacturing and quality metrics.
• Research, design, and develop processes to optimize productivity and workflow.
• Support sourcing and approval of suppliers for manufacturing processes and equipment. Identify alternative suppliers as needed.
• Ensure appropriate process documentation and validation to lead manufacturing transfer and scale-up.
• Train technicians and assemblers.

Other duties as required


Minimum of 5 years of experience in medical device development, production, or regulated industry.
• Experience with FDA’s Medical Device Regulations and ISO 13485
• Experience with fiber optic components and processing a plus.
• Experience with Minitab or other statistical software
• Strong knowledge of Medical Device Quality Systems
• Hands-on manufacturing experience for 4 years
• Knowledge of OCT or biomedical optics a plus
• Knowledge of SolidWorks
• Experience working in a startup environment a plus.
• Mechanical Design
• Team player with solid communication skills

• Bachelor’s Degree in a technical field or equivalent job experience.