Sr. Sustaining Engineer

Exactech, Inc. Gainesville , FL 32601

Posted 3 months ago

Purpose:

Manage and lead technical and sustaining engineering effort for products currently on the market.

Duties and Responsibilities (Key Deliverables):

1.Provide technical support for existing products by developing solutions for complex issues with relatively high organizational impact and with a high level of accountability and minimal supervisory oversight

2.Maintain products throughout their lifecycle by updating designs and design documentation to the latest national and international standards

3.Maintain product performance and quality by leading or assisting with issues relating to CAPAs, customer complaints and manufacturing processes, such as:

  • Non-conformance investigation and root cause analysis

  • CAPA resolution

  • Regulatory compliance

  • Product Design Verification and Design Validation

  • Design changes

  • Test methods and tooling design

  • Process enhancement and improvement

4.Follow strict adherence to policies and procedures associated with an FDA controlled environment

5.Work with clinician's technical issues and communicate solutions at the appropriate level

6.Integrate product performance activities with new product development to improve project delivery time and reduce post release production issues

7.Provide design, engineering, and analysis direction to other engineers and designers in the development and maintenance of orthopedic implants and instruments.

8.Apply sound engineering problem-solving techniques to product development and maintenance tasks including design, analysis, material selection, and inspection requirements and manufacturing process requirements

9.Lead a cross-functional project team including both internal and external team members such as consultants (e.g., design surgeons, scientists)



  1. Identify and assist with selection of external consultants

  2. 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.

  3. Assure timely and effective project completion according to the project plan and budget

  4. Review engineering designs for feasibility and accuracy

  5. Approve engineering drawings and specifications

  6. Procure and evaluate prototypes

  7. Identify, analyze and recommend new technologies or materials for specific product applications

  8. Assist in patent application preparation, patent review and patent analysis

  9. Support and participate in company and product strategy formulation

  10. Establish, develop and maintain strong working relationships with all necessary personnel to ensure smooth product design, development and commercialization

  11. Establish appropriate project plan (i.e. define tasks, dependencies, schedule and resource requirements).

  12. Complete and approve all Design History File documentation for assigned projects as required

  13. Assist in the resolution of manufacturing- or quality-related issues

  14. Participate in the establishment of goals, project plans and resource requirements

  15. Play a key role in setting product strategies

  16. 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 & industry meetings

  17. Serves as a mentor and technical leader for less experienced engineers and technicians

  18. Assist, teach and support other employees, teams, and sales personnel as necessary.

  19. Know and apply the Quality System and any appropriate Federal and International standards


Job Requirements:

Education: Bachelor's Degree in Mechanical Engineering, Biomedical Engineering or equivalent from an accredited institution required; Master's Degree preferred

Experience:

  • Minimum of 7 years of full-time medical device product development experience. This experience shall be in addition to any college internships. Relevant product development experience in other areas may be considered.

  • Must have successfully completed a minimum of one major project and three minor projects (e.g., line extensions, implant or instrument system modifications, etc.) of sufficient complexity. During the execution of these projects, must have been involved in all aspects of the product development process. A minor project involves the modification, adaptation or extension of an existing product or product line.

  • Must have a thorough 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 have demonstrated ability to work effectively in a team environment.

  • Must be creative and must have the ability to independently apply theoretical technical principles to product design.

  • Must have a practical working knowledge of orthopedics, anatomy and physiology, especially as related to the musculo-skeletal system, fundamentals of orthopedic surgery (major joints), mechanical test and measurement techniques/methods, engineering drawing interpretation, manufacturing and inspection methods/processes, FDA/ISO requirements, project management, orthopedic 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 applications and CAD applications.

  • Must have the ability to prioritize and manage several projects simultaneously.

  • Travel up to 20%

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Sr. Sustaining Engineer

Exactech, Inc.