Company Description:

Primary Purpose and Function
 
The Senior Product Development Engineer performs product design activities and coordinates production of prototypes for Product Development.  The Senior Product Development Engineer will also be responsible for design and development of products from initial concept through market release with little to no supervision, adhering to established company policies/procedures as well as applicable FDA/ISO regulations.
 
Essential Functions and Responsibilities
 

• Consults with the marketing staff, sponsoring surgeons, and manufacturing staff, as required, to facilitate proper design or products.
• Acts as a consultant on the design of special products.
• Prepares design drawings and acts as a consultant in the preparation of final drawings.
• Coordinates and provides technical assistance in the production of prototypes.
• Provides technical expertise for manufacturing, quality, marketing and sales, as directed.
• Travels, as required, for professional meetings or in association with product development or technical activities, which includes providing technical surgeon advice and key participant in surgeon design meetings
• Leads or co-leader of product development and programs.
• Works with the in-house legal department, outside legal consultants, and Government Patent Officials, as required, on patent searches, patent infringements, and patent applications and acts as technical expert on all design related materials and provides strategic analysis for continued direction.
• Develops technical documents, training programs, and technical presentations for customers and/or the sales force.
• Provides surgeons training through technical presentations, sawbones demonstrations, and VIP tours, etc.
• Practice integrity, reliability and honesty in all business transactions
• Project a positive company image at all times
• Work with co-workers as a team to ensure success
• Other duties as assigned by the Chief Operating Officer

 
Knowledge and Skill
 

• Ability to demonstrate strong analytical and problem solving skills
• Competent in MS Office products and efficient in email and internet applications
• Proficient in Solidworks & Solidworks PDM applications
• High accuracy in work and attention to detail
• Bachelor’s degree preferred from an accredited institution or equivalent
• 3-5 years’ experience in spine/orthopedic related field.
• In-depth knowledge of FDA 21 CFR Parts 801, 803, 806, 820 and 822 as well as ISO 13485 & 14971