This posting is for three Manufacturing Engineers to support a Product Remediation team working to evaluate and update all of our process and design validation and verification documentation in support of our fiber optic catheters.
The Manufacturing Engineers will work on an energetic and lively cross functional team with diverse strengths in the final stages of implementation for our process validation, execution of CAPA action plans, and design verification testing and reporting.
Successful engineers on our team are intensely curious, able to dig deep for root cause, analyze objectively, draw logical conclusions and follow through quickly to deliver solutions. We seek detail oriented folks with good technical writing skills and a critical eye to quality who can help us ensure the documentation we produce is fully supported, accurate, and well written. We seek passionate people with a positive mental attitude who can interact with ease within and outside our team to develop and deliver win-win solutions.
Knowledge of Master Validation Plans, Installation Qualification (IQ), Operation Qualification (OQ), and Performance Qualification (PQ), Software validation, test method validation, Gage R&R, and a clear understanding of FDA’s QSR and cGMP, and a good grounding in statistics would be a big plus.
Our team uses the Agile Scrum methodology to set the course of our weekly work. Weekly, we prioritize the team’s work, then plan our work in “sprints” and work together to achieve what we commit to. This methodology is ideal for high output, energetic, lively, positive contributors who like to feel part of a winning team that’s delivering on commitments. We are eager to find teammates who are excited by this atmosphere and the opportunity to make a big difference in the lives of patients!
• Four-year technical degree required, preferably in Engineering
• Typical experience required is Recent College Graduate or experienced medical device professional
• Statistical analysis skill set is desired
• An understanding of process validation relating to medical device regulations is preferred.
• A demonstrated ability to plan and run projects is highly desired.