Company Description:

Company Brief:

• SoundCath located in Canoga Park CA, provides a 2D and 4D intracardiac imaging platform for electrophysiology and structural heart procedures. In order to help the development and manufacturing of this cutting edge technology, SoundCath is looking for a mechanical engineer to help grow and design using modern techniques.

Job Description:

• In this position, the candidate will help with 2D & 3D CAD development, CAD designs for 3D printing, fixture design and technical documentation. The candidate will work with PCB houses, CNC houses and SoundCath’s 3D printing department. This position will require candidate to be knowledgeable in medical devices and quality systems in an FDA regulated field. Primary responsibilities for this role will be to manage R&D projects from early development to market release, create documentation according to design control requirements, hold design review meetings as needed, and perform phase reviews as required to meet R&D and manufacturing goals. This position does allow room for growth.

Qualifications:

• BS in Mechanical or Biomedical Engineering, or an equivalent engineering discipline;
• Minimum 1 year experience with medical devices; knowledge of ISO 13485 is a major plus!
• Experience and working knowledge of medical device design control process preferred;
• 3D printing experience in FDM or SLA preferred;
• Proficiency with 2D/3D CAD design using SolidWorks required;
• Excellent communication skills, both written and oral.

Responsibilities:

• Creates mechanical designs and applies engineering knowledge and skills as technical engineer during all phases of design and development;
• Generates and maintains computer-aided 2D/3D drawings (CAD) using SolidWorks, schematics and component specifications to document mechanical designs;
• Participates in hands-on fabrication and testing of prototypes using bench testing, animal and/or cadaver studies to evaluate product designs, and recommend and implement design modifications;
• Participates in product design/development (design control) from concept to post product launch for Europe (CE Mark) & US (FDA/510k) submissions;
• Performs detailed design reviews and tolerance analyses to achieve desired product performance, cost, reliability, and manufacturability requirements;
• Develops test plans and protocols and executes prototype testing and design verification testing;
• Creates engineering-level process instructions, bill of materials and related documentation;
• Assists in release and revision control of component drawings, specifications and other design documentation through the document control system;
• Effectively interfaces with suppliers to source and fabricate components;
• Participates in risk management activities (e.g. DFMEA) and implements risk mitigation strategies;
• Other duties as assigned as necessary.