To provide design, engineering, testing and analysis support to other engineers and designers in the development and maintenance of orthopedic implants and instruments.
Key Responsibilities
Provide design, engineering, testing 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, testing, inspection requirements and manufacturing process requirements.
Provide design of experiments guidance, schedule coordination and results analysis for tests that need to be conducted by outside test facilities.
Prepare and submit written and oral communications that describe product design testing, performance and project status. Areas of involvement include regulatory submissions, design history files, device evaluation and testing, manufacturing or supplier support, quality control, packaging, operating room support, device complaint evaluation, patent disclosures and instrument refurbishment.
Create, define and execute test methods, protocols, and reports for product testing to support product development, product maintenance and verification/validation activities.
Review requested product tests for feasibility and scientific validity.
Design tooling and fixturing required to execute testing assignments.
Establish appropriate project testing plan (i.e. define tasks, dependencies, schedule and resource requirements) and assure timely and effective completion.
Know and apply the Quality System and any appropriate Federal and International standards.
Education
Skills Knowledge and Expertise
Bachelor of Engineering degree from an accredited institution required
Experience
Must have a thorough understanding of theoretical technical principles in the following areas: design of experiments, materials testing (including static, fatigue, wear and impact), engineering statics and dynamics, mechanics of materials, mechanical engineering design, materials, statistics, finite element analysis 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 have a practical working knowledge of mechanical test and measurement techniques/methods, engineering drawing interpretation, manufacturing and inspection methods/processes, FDA/ISO requirements and the materials used in orthopedic implants and instruments
Must have the ability to prioritize and manage several projects simultaneously
Must have knowledge of various software packages including Microsoft Office applications, CAD applications and statistical applications
Travel up to 10%
Seniority level
Associate
Employment type
Full-time
Job function
Quality Assurance
Industries
Medical Equipment Manufacturing
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