Diagnostic Manufacturing Engineer
North Bergen, NJ
Full Time Regular
Blue Signal Search
Our client is a global leader in molecular diagnostics and technology. They deliver extensive medical testing expertise, working with state-of-the-art technology and practices to deliver clients accurate and fast results. They are hiring a Diagnostic Manufacturing Engineer to support process development to produce diagnostic technology.
The Diagnostic Manufacturing Engineer will utilize their background in the industry to optimize production processes for clinical manufacturing. This individual will be responsible for executing manufacturing operations and establishing key process parameters.
This Role Offers:
Competitive base salary and comprehensive benefits package. Highly respected industry reputation based on innovative products and technologies. Close-knit environment with likeminded self-starters. Work alongside a team of strong technical professionals offering services to truly impact and support those making advancements within the field of medicine. Culture of integrity, high performance, and quality customer care. Team of capable, experienced, and seasoned professionals at the top of their industry; very high average employee tenure.
Develop and implement programs for optimizing and standardizing manufacturing processes for diagnostic devices. Ensure processes are suitable for transfer to clinical manufacturing operations. Work cross functionally with manufacturing and supply chain teams to evaluate current manufacturing processes. Recommend improvements as needed. Oversee the inventory management system, ensuring transitions are accurately recorded. Maintain quality metrics and ensure proper documentation and reporting is in compliance with regulatory standards. Oversee equipment maintenance/troubleshooting efforts as needed. Maintain up to date knowledge of clinical manufacturing regulations and policies and communicate requirements effectively. Organize trainings to ensure production processes maintain compliance. Execute projects and programs in accordance with cGMP, ISO, and federal regulations.
6+ years of relevant experience in a clinical/diagnostic environment. BS in Biology, Biotechnology, or relevant science/engineering field. Master’s degree or higher preferred. Theoretical understanding of clinical manufacturing research and process implementation. Demonstrated success in process optimization and statistical analysis. Bench work experience in molecular testing, including PCR, microarray, and DNA extraction preferred. Analytical mindset with strong aptitude in solving problems; detail oriented. Ability to communicate cross functionally. Excellent listening, verbal, and written communication skills.
To apply for this job please visit www.bluesignal.com.