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 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 design testing, 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 necessary test 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 with advice on how to establish appropriate test plans for their products (i.e. design of experiment, define tasks, dependencies, schedule and resource requirements).
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 may be accomplished by attending seminars, classes, professional standard societies and industry meetings.
Know and apply the Quality System and any appropriate Federal and International standards.
Bachelor's Degree from an accredited Institution required
Minimum three years of product testing experience. This experience can include college internships or research assistant positions. Relevant testing experience in other areas may also be considered.
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 be creative and have the ability to independently apply theoretical technical principles to product design and product testing.
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 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.
Travel up to 10%
To fully meet team responsibilities, the individual will develop additional 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.
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)