Staff Engineer – Disposables
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:
- New product design, development, and optimization.
- Assist in the design and development process through ensuring Gentuity products and processes meet the customer requirements throughout design and commercialization.
- Ownership of Risk Management activities including FMEAs, Hazards analyses, etc.
- Develop robust experimental designs and supervise their execution.
- Develop test methods and fixturing to support experimentation.
- Data analysis and reporting.
- Support for biocompatibility and sterilization process development.
- Troubleshooting of designs and processes for robust manufacturing.
- Partner with manufacturing engineering, quality and operations to ensure that the transition of products through R&D, product approval and manufacturing scale up are smooth, timely and cost effective.
- Liaise with external suppliers
- Support company goals and objectives, policies and procedures – Good Manufacturing Practices, ISO, FDA and other international regulations.
- Participate in the creation of intellectual property.
Other duties as assigned
- 5-8 years of experience in a regulated medical device environment.
- A good working knowledge of the following areas:
- Mechanical design
- Design of molded components
- Statistical design and treatment of data
- CAD (2D & 3D)
- An analytical approach to problem solving.
- Adept at managing multiple tasks, task prioritization and working in a team.
- Ability to analyze, understand and effectively communicate technical information
- Excellent written and verbal communication skills.
- Catheter design a plus.
- A BS or MS in Mechanical or Biomedical Engineering or equivalent training/experience