As Principal Development Engineer you are responsible for quality, timely design and development of products which have significant impact on the company's short, mid, and long-term sales goals.
You may be responsible for supervision of one or more engineers for the duration of specific product development programs and you have direct responsibility for the commercialization of these products.
In addition, you are responsible for developing laboratory testing plans which will ensure safe and efficacious products that meet the design control requirements and the company's quality standards.
Ability to accept modifications to project timelines and priorities.
- Must be able to handle multiple tasks/projects and manage priorities accordingly.
- Must have a high tolerance for ambiguity.
- Must be able to work in a team environment and exert influence without alienating others.
- Must be extremely well organized with strong attention to details.
All Research and Development employees must follow all internal processes related to HCP consultant interaction, and may be in a position to initiate and verify HCP consultant’s services per the processes. Research and Development employees must follow all reporting guidelines for business expenses as they pertain to HCP interaction and involvement. All R&D employees are responsible for completing quarterly safety training per corporate policies on-time.
- Evaluate the design feasibility of new product ideas and use design control processes to develop new product designs from concept to commercialization. Provide support to Clinical and Regulatory Affairs for submissions and responses to FDA, BSi and other regulatory bodies.
- Develop product testing plans which will insure the safety and efficacy of products under development.
- Establish and maintain strong working relationships with all functional areas within the company to insure timely and smooth product development, design and commercialization. Typically this person will be considered the lead engineer for a major product development program.
- Maintain existing product segments in accordance with the company's and industry standards.
- Provide ongoing technical support to manufacturing areas within the company and/or vendors during production of current products.
- Prepare and submit written and oral communications to technical consultants and other functions within the company which describe the performance and intended design concepts of our products.
- Assist the corporate legal department as needed with patent disclosures and information necessary for patent submissions.
- Use sound engineering problem solving techniques to thoroughly review the decisions which can be made at this level. These decisions may include design, design analysis, material selection, process requirements, engineering specifications and inspection techniques depending on their scope and magnitude.
This position is accountable for design, development and the function of the individual's current and existing products to support global business goals. Limited supervision is required for individuals in this position.
Bachelor's degree in mechanical or biomedical engineering and/or a Master's or Ph.D. degree in engineering, science or materials science discipline is required.
Additional education and knowledge in the fields of orthopedics, orthopedic research, biomaterials, experimental and analytical stress analysis, fatigue testing, CAD/CAM skills, geometric tolerancing, project management and a working knowledge of manufacturing processes is required.
At least 10 years of experience in product development, design and project management. This individual should have a demonstrated ability to deal with abstract and conceptual design and project related problems on a daily basis. The individual must be team oriented and demonstrate effective problem solving skills and creativity.