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:
- Lead cross functional project teams to ensure program success and technical rigor
- Interface with external and internal customers including, surgeons, suppliers and hospitals to identify and understand new opportunities
- Provide knowledge of medical materials, medical device manufacturing
- Engineer the design, development, validation and release of products
- Develop customer and product requirements for new products
- Plan, implement, monitor and deliver designated tasks and deliverables
- Lead and guide design for manufacturing approaches for new products
- Provide guidance and lead FMEA’s and risk management exercises
- Provide strategy and lead the execution of Design Verification & Validation activities
- Develop and maintain an expertise level in product domain and competitive landscape
- Provide technical elements as needed to support regulatory submissions and patent applications/responses
- Direct cadaver, animal and bench studies as needed
- Participate in completing Design History File and in design review meetings
- Perform other related duties as assigned by supervisor
Secondary Job Responsibilities:
- Support business development and management activities
- Participate in research assignments including trade show and other conference attendance
- Respond to field questions related to products and projects when necessary
- Assist Sales & Marketing efforts regarding technical support on products
- Work with suppliers on design reviews and design transfer.
Educational Requirements: BS in engineering (ME and/or Biomedical a plus)