Product Development Engineer, Orthopedics (Job ID: 166 eng )

Location:  Austin, TX

Salary: $55,000 - $90,000

Position Summary:  

The Senior Product Development Engineer will be responsible for the design and manufacturing development of pyrocarbon small joint implants and related instrumentation. Responsibilities will include researching anatomical requirements, interfacing with surgeons and others end users to establish customer requirements, developing working plastic models, coordinating cadaver implant trials, developing design history files, ensuring appropriate design control and documentation, developing product design schedules and providing documentation to support regulatory approvals.  Responsibilities also include support to Product Development, Research/Testing, Manufacturing and Quality Assurance through the design of test fixtures and instrumentation, production fixtures and tooling and inspection tooling.  Emphasis is on executing these tasks with consideration and adherence to GMP and ISO requirements.  

Responsibilities:

1.      Research anatomical requirements of the implant.

2.      Work with Sales and Marketing and other functional areas to establish customer requirements for devices to be designed and developed. 

3.      Establish a product development schedule and budget.

4.      Develop working plastic models to implant for evaluation.

5.      Work with others within the Research and Development group to develop tests and instrumentation to evaluate product designs.  Design test equipment, fixtures and tooling as needed.

6.      Work with appropriate personnel to evaluate designs by means of finite element and related stress analyses.

7.      Develop a design history file to document the design’s evolution.

8.      Provide appropriate documentation to support regulatory submissions, ISO certification and Quality System adherence.

10. Design fixtures and tooling to support production of product and    instrumentation.

11. Design fixtures and tooling to support Quality Assurance inspections and function.

12. Provide drawings and documentation to outside vendors to facilitate production of parts and instrumentation.

13. Provide design and technical information to marketing to support the development of marketing tools such as brochures, technical bulletins, etc.

Scope:

Promotes a quality, professional and supportive climate. Maintains constant attention to regulatory requirements, GMP regulations and ISO requirements. Develops product development schedules. Works with Quality Assurance to ensure design control, to execute design development in conjunction with the company’s quality system and to provide appropriate documentation. Works with other engineers and designers to ensure that all aspects of the product design and requirements are met through careful planning of the production and quality operations. Works with Research engineers to ensure the development of appropriate inspection tests and controls with accompanying procedures and training instructions, and to design and develop appropriate tests and testing equipment to evaluate product sufficiently. Works with Manufacturing to support production through the design and development of needed fixtures and tooling.  Works with Sales and Marketing to obtain customer requirements and to provide design support. 

Qualifications: 

General:  Able to work full time, supervise people as assigned, operate CAD and ProEngineer design software, schedule design activities and have general knowledge of designing and documenting to GMP and ISO requirements.

Education: Minimum of a bachelor’s degree in Mechanical Engineering or related field and 5 years of related design experience.

 Experience:  Prefer individual with at least 5 to 7 years in designing of medical implantables. Knowledge of ProEngineer software and designing required. Knowledge of GMP, ISO and quality system practices required.

Skills:  Must know basic designing with ProEngineer, CadKey and related software. Must have strong interpersonal and organizational skills, possess multitasking capability, be computer literate, and be able to work independently. Basic understanding of MS Office applications.

Reporting/Supervising Relationships: As defined in the company organizational chart.

Job Demands: 

Physical demands:  May require minimal lifting and carrying of objects.

Environmental demands: Office environment. Environmental demands are minimal.

Travel: Minimal travel to industry trade shows and conventions; to hospitals to observe surgery for the confirmation of design requirements and performance; and to off-site vendors to define and review manufacturing processes.

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