Job Description
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.
SUMMARY OF PRIMARY DUTIES AND RESPONSIBILITIES:
• Manage engineering activities required to support Gentuity products through the commercialized life cycle.
• Provide engineering support for design and/or process changes of existing catheter and console products including ownership of change control documentation to support project execution.
• Provide recommendations and implement solutions for highly complex problems which reflect an understanding of business objectives and cost implications.
• Design and develop manufacturing processes, tooling and fixtures to meet business needs while enhancing process quality, productivity and safety.
• Provide engineering support for equipment qualifications and process verification and validation studies including protocol development, execution, data analysis and writing final reports.
• Ensure appropriate process documentation and validation to lead manufacturing transfer and scale-up.
• Develop/update work instructions, workmanship standards and process documents as needed and provide the required training for technicians and operators.
• Monitor and assess the performance of manufacturing processes and work with R&D and Quality to promptly address any emerging issues and implement solutions.
• Provide engineering support for non-conforming products, customer complaints, product returns and CAPA’s including leading root cause investigations and implementing short term and/or long term corrective actions to prevent recurrence and reduce business risk.
• Support continuous improvement of existing manufacturing operations for increased quality, productivity, workflow, reliability, efficiency and cost savings.
• Support sourcing and approval of suppliers for manufacturing processes and equipment.
• Provide support to resolve supply chain issues, component obsolescence issues and identification of alternate suppliers including interface with suppliers/customers as needed.
• Provide support for regulatory approvals and responses to regulatory questions for existing products.
• Proactively communicate project progress, risks and recommendations to management as appropriate.
• Perform other tasks and duties as required to contribute to the overall success of the team and organization.
EXPERIENCE/SKILL REQUIREMENTS:
5-8 years of hands-on experience in medical device development, production or regulated industry.
• Experience with ISO 13485 and FDA Quality System Regulations
• Experience with Minitab or other statistical evaluation software
• Lean Six Sigma training or certification and knowledge of statistical data analysis techniques (DOE, GR&R, Cpk, SPC)
• Risk management experience (DFMEA, PFMEA)
• CAD experience (preferably SolidWorks)
• Demonstrated project management skills with ability to prioritize multiple concurrent projects in a fast-paced environment and identify/resolve issues as they arise with minimal supervision.
• Cross functional team player with a strong work ethic, strong engineering and problem solving skills, creative thinking, good decision making skills, high attention to detail, effective interpersonal skills and excellent verbal/written communication skills.
• Experience with biomedical fiber optic components and processing is a plus.
EDUCATIONAL REQUIREMENTS:
• Bachelor’s degree in Mechanical or Biomedical Engineering (or related Engineering degree) plus 5-8 years of experience working in an FDA/ISO regulated medical device/medical equipment industry or equivalent education and years of experience.
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