Growing, fast paced medical device company focused on ground-breaking technologies for patients with respiratory diseases. Located in South OC and recently moved into a large new facility where they are moving forward with the industry's first wearable ventilator! This work environment offers employees opportunities to grow that are not available in some larger organizations.
- This position reports directly to the VP of R&D and is responsible for creating mechanical designs for new and existing ventilation products from concept to production within an FDA regulated quality system.
- The position will design both capital and consumable medical devices and sub-assemblies.
- The candidate will work in a team environment and will work closely with electrical, software, and systems engineers as well as with manufacturing and quality.
- The candidate will contribute to the technology and product road mapping process while facilitating engineering process and initiatives.
- The candidate will provide technical guidance for new product designs, optimization and problem solving.
- Design pneumatic systems and subsystems based on a good understanding of fluid mechanics. This includes systems that have flow control, pressure control, compressors, O2 concentrators, as well as associated consumables.
- Design mechanical enclosures and sub system assemblies.
- Provide technical support for the other engineering disciplines including electrical, software, quality and manufacturing engineers.
- Ensure that designs meet industry and regulatory standards.
- Conduct various tests to verify and validate design capabilities.
- Assist in research and development of new products.
- Provide guidance on designs to meet testing requirements.
Required Skills and Experience:
- Bachelor’s Degree in Mechanical Engineer or equivalent engineering discipline, a Master’s Degree is highly desired.
- 10 plus years of experience designing medical device or devices in other regulated industry.
- Experience with Solidworks and PDM Works
- Experience with FDA GMPs and ISO 13485
- Knowledge of EN60601-1, ISO 10993, RoHS & REACH
- Experience with managing requirements, configuration, issue tracking tools, etc.
- Demonstrated leadership abilities in test and issue ownership.
PLEASE SUBMIT YOUR RESUME FOR IMMEDIATE CONSIDERATION TO LAKEFOREST@KIMCO.COM
- Provide guidance and mentoring to others.
- Self-motivated, deadline oriented, detailed and able to work in a fast paced environment.