Provide design, engineering, and analysis support to other engineers and designers in the maintenance of orthopedic implants and instruments currently on the market.
Duties and Responsibilities (Key Deliverables):
1. 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.
2. Apply sound engineering problem-solving techniques to product improvement and maintenance tasks including design, analysis, material selection, inspection requirements and manufacturing process requirements.
3. Maintain product performance and quality by assisting with issues relating to CAPAs, customer complaints and manufacturing processes, such as:
a) Non-conformance investigation and root cause analysis
b) CAPA resolution
c) Regulatory compliance
d) Product design verification and design validation
e) Design changes
f) Test methods and tooling design
g) Process enhancement and improvement
4. Prepare and submit written and oral communications that describe product design concepts, attributes and 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.
5. Define and execute product testing and validation protocols.
6. Establish appropriate project plan (i.e. define tasks, dependencies, schedule and resource requirements).
7. Complete and approve all Design History File documentation for assigned projects as required.
8. Lead a cross-functional project team (including both internal and external team members such as orthopedic surgeons) of one or several minor maintenance projects. A minor project involves the modification, adaptation or extension of an existing product or product line.
9. 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.
10. Know and apply the Quality System and any appropriate Federal and International standards.
11. Assist and support other employees, teams, and sales personnel as necessary.
Education: Bachelor’s Degree in Mechanical Engineering, Biomedical Engineering or equivalent from an accredited institution required; Master’s Degree preferred
• 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 the ability to apply parametric solid modeling and drafting conventions to design projects.
• Must have knowledge of various software packages including Microsoft Office applications and CAD applications.
• 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.
• Travel 5-10%
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)