The Senior Engineer is responsible for supporting product development programs and projects for the Surgical and Sports Medicine Franchise. The incumbent will be a technical individual contributor experienced in medical device product design, development and manufacturing processes in an FDA compliant development environment.
Roles and Responsibilities
- Lead the technical design effort working with a project manager through the development and commercialization process.
- Support projects by integrating all aspects of design work from new product development partners, both internal and external KCI suppliers. Ensure that the technical output of assigned projects meets the design input requirements.
- Contributes to the project schedule for design and technical aspects of the project and provides input as a member of the technical team.
- Works effectively with research and development team members as well as extended team members across the organization, to include, but not limited to engineering, scientists, legal, labeling, human factors, etc.
- Contributes to intellectual property discussions related to assigned projects, identifies and documents findings per KCI processes.
- Interact with KCI customers to foster an innovative and interactive dialog about KCI products.
- Ensures technical project activities are consistent with the KCI product development and design control process. Assists project manager to drive maintenance and completion of project deliverables required by the KCI product development process.
- Requires a Bachelor Degree in Engineering such as Mechanical, Electrical, Computer, General Engineering, and/or Engineering Sciences.
- Requires 5-8 years with a Bachelors Degree or (3-6) with a Masters experience in product development within a cross functional development environment.
- Product development experience in regulated design environments - specifically medical device development, Food and Drug Administration (FDA) or International Organization for Standardization (ISO) registered work experience.
- Ability to deal effectively with all employees and external business contacts while conveying a positive, service oriented attitude.
- Ability to communicate effectively, both verbally and in writing.
- Ability to maintain complete confidentiality and discretion in business relationships and exercise sound business judgment.
- Experience in Manufacturing Processes for commercial products.
- Experienced in using Solidworks.
- Project management training and experience.
- Medical product design and development experience.