Tigon Medical
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    • Home
    • Procedures
      • Rotator Cuff
      • Labrum
      • Bicep Tenodesis
      • Achilles
      • Brostrom
    • Products
    • Treatments
    • Careers
    • IFU
    • About Us
    • Contact
  • Home
  • Procedures
    • Rotator Cuff
    • Labrum
    • Bicep Tenodesis
    • Achilles
    • Brostrom
  • Products
  • Treatments
  • Careers
  • IFU
  • About Us
  • Contact

Product Development Engineer

Position Description

This position is responsible for the design and development of orthopedic medical devices, device accessories and processes that compliment our current product line. 


COMPETENCIES & RESPONSIBILITIES (included but not limited to):  

  • Design and develop medical devices and accessories.  
  • Organize projects and maintain Design History Files (DHF)
  • Write and Submit 510(k)s to the FDA
  • Use established procedures to improve existing medical devices and accessories. 
  • Continually optimize manufacturing procedures to produce less expensive, higher quality medical devices. 
  • Perform test procedures to verify and validate product quality and efficacy. 
  • Document all developments in scientific notebooks 
  • Complete Document Change Orders (DCO) document and control processes and procedures. 
  • Assist in the completion of new and existing product design validations. 
  • Complete design drawings in Solidworks or similar drafting program and create prototypes to progress the development through its design stages.  
  • Assist in training personnel to processes associated with design and development of medical devices and accessories. 
  • Develop efficient (i.e. cost, material, time, etc.), user-friendly manufacturing processes.  
  • Assist in the resolution, documentation, customer responses of product complaints. 
  • Coordinate and assist in corrective and preventative action activities and solutions 
  • Comply with appropriate regulatory agencies (i.e. GMP, ISO, FDA, etc.) and associated quality systems.
  •  Communicate with strategic vendors and suppliers.  


QUALIFICATIONS:  

  • 4yr degree in applicable field of study, preferably engineering (ME, BioMedE)  
  • 3+ years experience in medical device industry 
  • Strong understanding of design controls
  • Understanding of quality and regulatory requirements for Class 1 and Class 2 devices
  • Good written and verbal communication skills 
  • Project management, self-starter and self-organizer. 
  • Excellent problem Solver  

Apply

Tigon Medical

303 Najoles Rd. Suite 104, Millersville, Maryland 21108. United States of America

(410) 544-2833

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