Class III remediation project. The person in this role will be responsible for providing technical expertise to support ongoing engineering activities that enhance or sustain their products.
- Development and execution of testing approaches on projects: drafting test plans and reports..
- Conceptualize, develop and validate test methods in support of product development and regulatory submissions.
- Support component qualification and the development of PDP documents
- Document all work according to GMPs and SOPs in compliance with the company's quality system.
- Work with engineers to evaluate designs for new products, product revisions, components, assemblies or tools.
- Collaborate with R&D, Manufacturing, Regulatory and Quality departments to coordinate focused efforts on investigations.
- Assess failure modes and conduct risk analyses.
- Mitigate risks associated with identified hazards in Design and Process FMEA.
- Excellent teamwork and organizational skills.
- Excellent written and verbal communication skills.
- Minimum 4 years of engineering experience
- Minimum 3 years of Class III medical device experience required
- Bachelors Degree in Engineering: Mechanical, Biomedical, or Boengineering
- Experience with R&D: designing tests, writing protocols, executing tests, compiling data, completing all necessary documentation
- EU MDR experience preferred
Sthree US is acting as an Employment Business in relation to this vacancy.