Senior Product Development Quality Engineer

OrthoHelix Surgical Designs is a leading edge medical device company developing and selling a comprehensive line of innovative implants and instruments for use in hand and foot reconstructive surgery.

Our mission is to develop and deliver innovative orthopedic implants and instruments that elevate the art of small bone surgery.


Our medical advisory board consists of top surgeons practicing in the hand/wrist, foot/ankle and podiatric surgery.

Key Duties and Responsibilities:

 Supplier Quality / Manufacturing Engineering responsible for supplier selection, development, and support for medical implant and instrument development projects.Design and qualification of custom inspection gages, fixtures, and methods
Good understanding of quality concepts and tools including ISO 13485;2003 and the FDA QSR  Must be able to read blueprints and diagrams.  Solid Works experience a plus.  Must be computer proficient (Microsoft Office Suite).  Supply Chain Engineer experience in a medical device environment is strongly preferred: Ability to assist suppliers with the development and implementation of statistical sampling plans and inspection procedures.Monitor, review and report on vendor performance.  Initiate corrective action as appropriate.Determine and implement statistically valid sampling plans, equipment requirements, inspection procedures, acceptance criteria and training requirements for new devices and implants.Serve as technical resource for development projects such as alternative measurement/testing methodologies and pre-production qualification programs.Assist in resolving internal and external audit findings and observations in Inspection.  Develop and implement corrective actions as appropriate.

 

Education/Experience Necessary:

 Education:  BS Engineering discipline
Minimum 6 – 8 years of overall experienceMinimum four years experience in Quality or Manufacturing Engineering including supplier development.Experienced with statistical techniques, including design of experiments (DOE); able to analyze results.  Expertise in the areas of statistical plans and lot acceptance sampling procedures.Must have knowledge of manufacturing processes used in the creation of medical implants such as swiss turning, vertical milling, cleaning, passivation, titanium anodize, etc.Experienced in developing inspection and testing techniques for medical devices including CMM, vision etc.Must be able to read and interpret blueprints.Must have a thorough understanding of problem solving and quality improvement tools and techniques.Extensive knowledge of ISO/QSR requirements.Must be willing to travel 40-60%