Product Development Engineer II - Medical Devices:
Use mechanical engineering knowledge to design and develop innovative medical devices, components/subsystems, or processes in support of company’s strategic plan. Participates in patent applications resulting from research.
Responsibilities of the Product Development Engineer:
- Develop new devices and components. Perform verification and Validation activities.
- Perform testing on devices and analytical analysis on devices.
- Maintains all documentation and design history files per establish standards.
- Develop new processes and perform validations.
- Utilizes engineering software such as SolidWorks, as required.
- Develops engineering schedules and projects as assigned.
- Creates Engineering Technical Reports, memos, Engineering Changes and other documentation as needed.
- Resolves and/or facilitates the resolution of problems including identifying causes to prevent re-occurrence.
- Maintains high level of professionalism in attitudes and communication with fellow employees and customers.
- Maintains a clean and professional office and work area.
- Complies with U.S. Food and Drug Administration (FDA) regulations, ISO regulations, company policies, and processes.
- Performs other related duties and responsibilities as assigned.
Requirements of the Product Development Engineer:
- Bachelor of Science degree in mechanical engineering or related engineering field.
- Three (3) plus years of product development experience in medical devices.
- Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
- Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
- Multitasks, prioritizes and meets deadlines in timely manner.
- Strong organizational and follow up skills, as well as attention to detail.
- Ability to travel approximately 10% .
- Ability to maintain regular and predictable attendance.
- Strong back ground in bio-materials
- Strong CAD abilities.