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.
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.
Requirements
Pursuing a bachelor’s or master’s degree in Mechanical Engineering, Biomedical Engineering or equivalent from an accredited institution required
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 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.