|Reports To:||VP, Research and Development|
Summary of Position with General Responsibilities:
This position is responsible for the conceptualization, design, documentation, testing, sustaining engineering, and case support of new and existing implants and instruments.
PRINCIPAL RESPONSIBILITIES include the following. Other duties may be assigned.
- Conceptualize and design novel implants and instrumentation.
- Prepare SolidWorks models and final production drawings.
- Identify all tasks required to complete project assignments according to Design Control procedures.
- Define and execute or review in-house mechanical product (implant and/or instrument) testing in support of product design evaluations and regulatory submissions.
- Perform/Review cadaveric product testing for design evaluation or to support sales activities.
- Interact with vendors and surgeon consultants to communicate progress and facilitate critical design decisions and trade-offs.
- Provide technical support for manufacturing, quality, marketing, and sales.
- Serve as product specialist, training surgeons and assisting in live surgeries (travel as necessary).
- Operate in compliance with applicable regulations (FDA and CE).
- Ability to conceptualize designs for orthopedic implants and instrumentation.
- Ability to evaluate the fundamental performance metrics of implant and instrument concepts, whether mechanical performance, clinical performance, manufacturability, ergonomics, or biocompatibility/safety.
- Ability to multi-task projects with complex scheduling of key technical resources and deliverables.
- Works with minimum supervision.
- Has appreciable latitude for unreviewed action or decision.
- No supervisory responsibility with the exception of co-ops or interns.
- Bachelors in Mechanical Engineering or Biomedical Engineering required.
- 2-5 years medical device development experience in FDA regulated environment, preferably in design of orthopedic implants and instruments.
- Ability to comprehend complex mechanism designs and 3-D CAD principles as well as detailed mechanical specifications and drawings.
- Ability to understand and apply GD & T and tolerance stack up analysis.
- Minimum computer skills: 3-D CAD, spreadsheets and word processing programs.
- Ability to conduct problem solving exercises utilizing various data analysis principles.
- Understanding of design controls, DHF, and Risk Management.
- Basic prototyping/machining skills desired
- Ability to read, analyze and interpret common scientific and technical journals.
- Ability to respond to common inquiries or complaints from customers.
- Ability to communicate effectively before large groups of customers or employees.