About the role
The Manager of Development Engineering leads cross-functional teams to design, develop, and validate medical-grade products while ensuring technical rigor and regulatory compliance. They interface with internal and external stakeholders, including surgeons and suppliers, to identify opportunities and guide the product lifecycle from requirements to release.
What they look for
Requirements
Candidates must hold a Bachelor of Science degree in engineering, with a preference for Mechanical or Biomedical backgrounds. The role requires significant experience in medical device manufacturing, risk management, and design verification processes.
Full 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)
