Associate Test Engineer

Department: Engineering, Extremities

Employment Type: Full Time

Location: Gainesville, FL

Reporting To: Manager, Test Engineering

Description

Key Responsibilities

• Provide design, engineering, testing and analysis support to other engineers and designers inthe 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 experiment 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 designtesting, attributes, 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.
• Assure timely and effective test completion according to the project plan and budget.
• Review requested product tests for feasibility and scientific validity.
• Approve test reports for accuracy and completeness.
• Participate in product design review meetings.
• Procure and evaluate necessarytest equipment.
• Design tooling and fixturing required to execute testing assignments.
• Establish appropriate project testing plan (i.e. define tasks, dependencies, schedule and resource requirements).
• Provide product development engineers withadvice on how to establishappropriate test plans for their products (i.e. design of experiment, define tasks, dependencies, schedule and resource requirements).
• Play a key role in setting product-testing strategies for new product development.
• Study and recommend improvements to existing product testing protocols and types. This entails staying "up to date" on emerging material and medical product testing technologies. This maybe accomplished by attending seminars, classes, professional standard societies and industry meetings.
• Know and apply the Quality System and any appropriate Federal and International standards

Skills Knowledge and Expertise

• Bachelor's Degree from an accredited institution required.

• Minimum one year of product testing experience. This experience can include college internships or research assislant positions. Relevant testing experience in other areas may also be considered.
• Must have a thorough understanding of theoretical technical principies inthe 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.

• 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 principies to product design and product testing.
• Must have a practical working knowledge of mechanical test and measurement techniques/methods, engineering drawing interpretation, manufacturing and inspectionmethods/processes, FDNISO requirements and the materials used in orthopedic implants and instruments.
• Must have the ability to prioritize and manage several test projects simultaneously.
• Must have the ability to apply parametric solid modeling and drafting conventions to testing projects.
• Must have knowledge of various software packages including Microsoft Office applications, CAD applications and statistical applications