Essential Job Duties and Responsibilities
- Contributes to development of new concepts from initial design to market release.
- Contributes to execution of established Design Verification test protocols.
- Conducts feasibility studies of the design to determine ability to function as intended.
- Maintains detailed documentation throughout all phases of product development.
- Contributes to risk analysis for products under development.
- Coordinates activities with outside suppliers and consultants to ensure the delivery of supplies or services needed to meet scheduled timelines.
- Participates in client meetings. Proactively communicates with team to ensure an ongoing two-way exchange of information.
- Any other duties as assigned.
Education and Experience Requirements
- Bachelor's degree in Mechanical, Plastics or Biomedical Engineering is desired. In lieu of a degree, previous experience in a similar or exact role may be considered.
- 0 – 2 years of medical device design and development experience is desired.
Skills and Abilities
- Ability to interact with clients and companies in a professional manner.
- Customer focus with proficient communication skills, written and oral.
- Flexibility, persistence, resourcefulness, a drive to succeed, and an entrepreneurial spirit.
- SolidWorks 3D CAD proficiency.
- Familiarity with Design for Manufacturability and Assembly (DFM / DFA) is desired.
- Some experience working with operations to develop strong manufacturing process instructions and operator training to ensure smooth product transition into the manufacturing environment is desired.
- Familiarity with FDA QSR and ISO 13485 medical device regulations is desired.
- Familiarity with probability and statistics.
Working Conditions and Physical Demands
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.