Senior Mechanical R&D Engineer

 Position Summary:

  • 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

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