Job Opportunity:
We are seeking a highly skilled Principal R&D Engineer to provide technical leadership and expertise in the development of device design requirements and specifications.
About the Role:
* Lead the development of device design requirements and specifications.
* Provide technical guidance on robust device and product characterization throughout the design development program.
* Collaborate with cross-functional teams to ensure compliance with regulatory requirements.
* Design experiments and manufacturing trials to validate device performance.
* Evaluate and analyze data from analytical and manufacturing processes.
* Trending and statistical analysis of data.
Requirements:
* Master's or Doctoral degree in Engineering or Science with 7 years' experience in late-stage R&D or Technical Support environment.
* Proven experience working as an Engineer or Scientist in regulated and GMP environments.
* Knowledge of ISO 13485 and FDA 21 CFR Part 820 Design Control requirements.
Skills:
* Excellent problem-solving skills and ability to work independently.
* Strong communication and collaboration skills.
* Able to operate effectively in a fast-paced environment.
What We Offer:
* A dynamic and innovative work environment.
* Opportunities for professional growth and development.