Senior Mechanical R&D Engineer
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.
Duties and Responsibilities:
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.
Excellent problem solving and troubleshooting skills.
Strong attention to detail.
Demonstrated leadership abilities in test and issue ownership.
Ability to provide guidance and mentoring to others on project.
Ability to motivate self and meet deadlines in fast-paced environment