
Senior Device Development Engineer
7 days ago
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.
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