Department: Engineering, Extremities
Location: Gainesville, FL
Description
Provide design, engineering, and analysis support to other engineers and designers in the maintenance of orthopedic implants and instruments currently on the market.
Key Responsibilities
- Provide design, engineering, and analysis support to other engineers and designers in the maintenance of orthopedic implants and instruments currently on the market as part of continuous improvement.
- Apply sound engineering problem-solving techniques to product improvement and maintenance tasks including design, analysis, material selection, inspection requirements and manufacturing process requirements.
- Maintain product performance and quality by assisting with issues relating to CAPAs, customer complaints and manufacturing processes, such as:
- Non-conformance investigation and root cause analysis
- CAPA resolution
- Regulatory compliance
- Product design verification and design validation
- Design changes
- Test methods and tooling design
- Process enhancement and improvement
- Prepare and submit written and oral communications that describe product design concepts, attributes and performance and project status. Areas of involvement include device evaluation and testing, manufacturing or supplier support, quality control, packaging, operating room support, device complaint evaluation, patent disclosures and instrument refurbishment.
- Study and recommend improvements to existing products and processes. This entails staying “up to date” on emerging material and medical product technologies. This may be accomplished by attending seminars, classes and industry meetings. Contribute to the timely and accurate completion of the projects and tasks assigned to his/her team.
- Know and apply the Quality System and any appropriate Federal and International standards.
- Assist and support other employees, teams, and sales personnel as necessary.
Skills, Knowledge And Experience
Education:
- Pursuing a bachelor’s or master’s degree in Mechanical Engineering, Biomedical Engineering or equivalent from an accredited institution required
Experience:
- 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.
Functional/Technical Knowledge, Skills and Abilities Required:
- Must have excellent communication (verbal & written) and organizational skills.
- Must have excellent interpersonal skills and must be able to work effectively in a team environment.
- Must be creative and have the ability to independently apply theoretical technical principles to product design.
- Must have knowledge of various software packages including Microsoft Office applications and CAD applications.
- Must have a practical, working knowledge and skills in anatomy and physiology, especially as related to the musculo-skeletal system, fundamentals of orthopedic surgery (major joints), mechanical test methods and procedures, quality and inspection methods, manufacturing processes and methods, FDA/ISO requirements, project management, orthopedic implants and the materials used in orthopedic implants and instruments.
- Travel 0-10%
