Biologics Product Design and Development Engineer

Team

Biologics

Minimum Requirements for Fulfilling Team Role

Education

• BS in Mechanical Engineering, Biomedical Engineering or equivalent relevant experience

Experience

• Minimum of five years of full-time medical device product development experience, including management of the Design Control process from project initiation through product launch

Other

• 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 a practical working knowledge of orthopaedics, anatomy and physiology, especially as related to the musculo-skeletal system, fundamentals of orthopaedic surgery (major joints), mechanical test and measurement techniques/methods, engineering drawing interpretation, manufacturing and inspection methods/processes, FDA/ISO requirements, project management, orthopaedic implants and the materials used in orthopedic implants and instruments
• 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 and CAD applications
• Excellent interpersonal skills to allow effective participation in project teams
• Self motivated person with initiative to complete tasks independently
• Excellent oral and written communication skills
• Excellent understanding of current Good Manufacturing Practices (cGMP)  and a knowledge of Quality System Regulations (QSR) is a plus
  

Responsibilities Include But Are Not Limited To

1. Provide design, engineering and analysis support to other engineers and designers in the development and maintenance of orthopaedic implants and instruments.
2. Apply sound engineering problem-solving techniques to product development and maintenance tasks including design, analysis, material selection, inspection requirements and manufacturing process requirements.
3. Prepare and submit written and oral communications that describe product design concepts, attributes and performance and project status.   Areas of involvement include customer and sales support, 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.
4. Lead cross-functional design and development project teams (including both internal and external team members such as orthopaedic surgeons).
5. Define and execute product testing and validation protocols.
6. Establish appropriate project plans (i.e., define tasks, dependencies, schedule and resource requirements).
7. Complete and approve all Design History File documentation for assigned projects as required.
8. Assume responsibility for maintenance and revision of Design History Files for existing products.
9. Assure timely and effective project completion according to the project plan and budget.
10. Review engineering designs for feasibility and accuracy.
11. Approve engineering drawings and specifications.
12. Procure and evaluate prototypes.
13. Assist in the resolution of manufacturing- or quality-related issues.
14. Study and recommend improvements to existing products and processes. Perform device evaluations.
15. Participate in the establishment of goals, project plans and resource requirements.
16. Identify, analyze and recommend new technologies or materials for specific product applications.
17. Assist in patent application preparation, patent review and patent analysis.
18. Know, apply and contribute to improvement of Exactech Quality System in all responsibilities at Exactech.
19. Assist and support other employees, teams and sales personnel as necessary.
20. Other responsibilities of the Biologics Team, as necessary.

For more information, send e-mail to human.resources@exac.com.