Experience:
No experience
Employment Type:
Full time
Posted:
4/21/2019
Job Category:
Engineering
electro-mechanical Engineer
(This job is no longer available)
Exactech, Inc. | Gainesville, FL
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Job Description

Duties and Responsibilities (Key Deliverables):

1. Lead a cross-functional project team (including both internal and external team members such as orthopedic surgeons) of one major and several minor development projects.

2. Have a general ability to apply knowledge of mechanical engineering and scientific principles to develop, design, analyze, test, and validate solutions for complex electromechanical systems and parts.

3. Have the ability to develop complex electro-optical and opto-mechanical products including designs, drawings, performance predictions and verification requirements.

4. Support the DfM/DfA/DfT activities of electro-mechanical components and their integration into the overall design of the assembly.

5. Establish in-process and finished good test requirements for electro-mechanical components and capital equipment, troubleshooting and failure analysis of electro-mechanical components and assemblies utilizing basic tools such as scopes, meters, inspection instruments, etc.

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

7. Determine needs assessment for development projects.

8. 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.

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

10. 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.

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

12. Support and participate in company and product strategy formulation.

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

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

15. Interact with sales force to assist with training of products in the field.

Job Requirements:

Education: Bachelor's Degree in EE or EM from an accredited institution required; Master's Degree preferred

Experience:

* Minimum of 3 years of full-time product development experience with leading and conducting process development and validation activities for electro-mechanical components and capital equipment is required.
* This experience shall be in addition to any college internships.
* Experience in a highly regulated environment (e.g., medical device) is preferred.
* Relevant product development experience in other areas may be considered.

Functional/Technical Knowledge, Skills and Abilities Required:

* Required skills and abilities:
* 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.
* Required functional and technical knowledge:
* Knowledge of FDA and ISO requirements.
* Knowledge of GMP regulations is required.
* Knowledge and experience with RoHS, UL and IEC 60601 product safety and EMC requirements are preferred.
* 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, project management, orthopedic implants and the materials used in orthopedic implants and instruments.
* Must have knowledge of various software packages including Microsoft Office applications, CAD applications and data analysis tools (e.g., Matlab, Excel, Python).
* Travel 5-10%.

About Exactech, Inc.

Exactech, Inc. (Exactech) develops, manufactures, markets, distributes and sells orthopaedic implant devices, related surgical instrumentation and biologic services to hospitals and physicians in the United States and internationally. The Company's revenues are principally derived from sales and distribution of its joint replacement systems, including knee, hip, spine and implant systems, and distribution of biologic products and services and bone cement materials used in orthopaedic surgery and dental procedures. Exactech manufactures some components of its knee, extremity and hip joint replacement systems at its facility in Gainesville, Florida utilizing automated computer aided manufacturing equipment. Its cellular based manufacturing processes, which are organized in groups, or cells, are focused on specific product lines. Additionally, the Company acquires and distributes other products and services through agreements, with Tecres S.p.A, RTI Biologics, Inc. and Biomatlante SARL. (Source: 10-K)