Senior Development Engineer Job Description
Description: Design medical grade products that are solutions to end user needs through regular interaction with engineering, quality, sales and customers. Serve as project leader on cross functional project teams. He/she must conform to the guidelines described in the company’s quality system and other policies.
Primary Job Responsibilities
- 01Lead cross functional project teams to ensure program success and technical rigor
- 02Interface with external and internal customers including, surgeons, suppliers and hospitals to identify and understand new opportunities
- 03Provide knowledge of medical materials, medical device manufacturing
- 04Engineer the design, development, validation and release of products
- 05Develop customer and product requirements for new products
- 06Plan, implement, monitor and deliver designated tasks and deliverables
- 07Lead and guide design for manufacturing approaches for new products
- 08Provide guidance and lead FMEA’s and risk management exercises
- 09Provide strategy and lead the execution of Design Verification & Validation activities
- 10Develop and maintain an expertise level in product domain and competitive landscape
- 11Provide technical elements as needed to support regulatory submissions and patent applications/responses
- 12Direct cadaver, animal and bench studies as needed
- 13Participate in completing Design History File and in design review meetings
- 14Perform other related duties as assigned by supervisor
Secondary Job Responsibilities
- 15Support business development and management activities
- 16Participate in research assignments including trade show and other conference attendance
- 17Respond to field questions related to products and projects when necessary
- 18Assist Sales & Marketing efforts regarding technical support on products
- 19Work with suppliers on design reviews and design transfer.
Educational Requirements: BS in engineering (ME and/or Biomedical a plus)
United States
