About the Role
This role involves creating, testing, and refining medical device designs while ensuring compliance with quality and safety regulations throughout the product lifecycle.
Responsibilities
- Develop detailed design documentation for medical devices
- Conduct design verification and validation testing
- Collaborate with cross-functional teams on product development
- Apply engineering principles to solve design challenges
- Create and maintain design history files
- Perform risk assessments for new and existing products
- Support regulatory submissions with technical data
- Evaluate materials and components for device integration
- Lead design transfer to manufacturing teams
- Troubleshoot technical issues during prototyping
- Ensure compliance with ISO and FDA standards
- Participate in design reviews and technical evaluations
- Optimize designs for manufacturability and usability
- Manage multiple project timelines and deliverables
- Utilize CAD software for 3D modeling and drafting
- Support non-conformance investigations and CAPA activities
- Conduct bench testing and performance evaluations
- Interface with suppliers on component specifications
- Apply human factors principles to product design
- Maintain accurate engineering records and reports
- Drive continuous improvement in design processes
- Assist in technology transfer across global sites
- Stay current with industry standards and innovations
- Provide technical guidance to junior engineers
- Support product lifecycle management activities
Compensation
Competitive salary and benefits package offered
Work Arrangement
Hybrid work model with partial on-site requirements
Team
Collaborative engineering team within medical technology development
Why Join Us
- Opportunity to work on innovative healthcare solutions that improve patient outcomes
- Supportive environment that values engineering excellence and professional growth
- Access to advanced tools and technologies in a global organization
Work Environment
- Hybrid schedule combining remote and on-site work
- Collaborative culture with regular team interactions
- Facilities equipped with engineering labs and prototyping resources
Sponsorship available for qualified candidates
