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- Lead a cross-functional project team of one major and several minor development projects, including both internal and external team members such as orthopedic surgeons. ">
- Identify and assist with selection of clinical evaluators and design surgeons. ">
- Obtain feedback from clinicians to develop products. ">
- Interact with sales force to assist with training of products in the field. ">
- Determine needs assessment for development projects. ">
- Provide design, engineering, and analysis support to other engineers and designers in the development and maintenance of orthopedic implants and instruments. ">
- Apply sound engineering problem-solving techniques to product development and maintenance tasks including design, analysis, material selection, inspection requirements and manufacturing process requirements. ">
- Prepare and submit written and oral communications that describe product design concepts, attributes and performance and project status. ">
- Define and execute product testing and validation protocols. ">
- Establish appropriate project plans (i.e. define tasks, dependencies, schedule and resource requirements). ">
- Complete and approve all Design History File documentation for assigned projects as required. ">
- Assure timely and effective project completion according to the project plan and budget. ">
- Review engineering designs for feasibility and accuracy. ">
- Approve engineering drawings and specifications. ">
- Procure and evaluate prototypes. ">
- Assist in the resolution of manufacturing- or quality-related issues. ">
- Study and recommend improvements to existing products and processes. ">
- Perform device evaluations. ">
- Participate in the establishment of goals, project plans and resource requirements. ">
- Identify, analyze and recommend new technologies or materials for specific product applications. ">
- Assist in patent application preparation, patent review and patent analysis. ">
- Recommend project priorities based on perceived market needs. ">
- Support and participate in company and product strategy formulation. ">
- Know and apply the Quality System and any appropriate Federal and International standards. ">
- Bachelor's Degree in Mechanical Engineering, Biomedical Engineering or equivalent from an accredited institution required; Master's Degree preferred. ">
- Minimum of 3 years of full-time medical device product development experience. This experience shall be in addition to any college internships. ">
- Must have successfully completed a minimum of three minor projects (e.g., line extensions, implant or instrument system modifications, etc.) of sufficient complexity. ">
- Must have a basic understanding of theoretical technical principles in the following areas: mechanical drafting, geometrical dimensioning and tolerancing, computer aided design, engineering statics and dynamics, mechanics of materials, mechanical engineering design, materials, and technical writing. ">
- Must have excellent communication (verbal & written) and organizational skills. ">
- Must have excellent interpersonal skills and must have demonstrated ability to work effectively in a team environment. ">
- Must be creative and must have the ability to independently apply theoretical technical principles to product design. ">
- Must have a practical working knowledge of orthopedics, anatomy and physiology, especially as related to the musculo-skeletal system, fundamentals of orthopedic surgery (major joints), mechanical test and measurement techniques/methods, engineering drawing interpretation, manufacturing and inspection methods/processes, FDA/ISO requirements, project management, orthopedic implants and the materials used in orthopedic implants and instruments. ">
- Must have the ability to apply parametric solid modeling and drafting conventions to design projects. ">
- Must have knowledge of various software packages including Microsoft Office applications and CAD applications. ">
- Travel 5-10%. ">
Product Development Engineer - Gainesville - Exactech

Description
Product Development Engineer - Upper Extremities
">This role leads a cross-functional project team of one major and several minor development projects, including both internal and external team members such as orthopedic surgeons.
">Key Responsibilities:
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Education:
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Experience:
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Functional/Technical Knowledge, Skills and Abilities Required:
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Company: Gainesville, FL. Reporting To: Manager E&D.
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