Manufacturing Engineer I
6 months contract
The Manufacturing Engineering team is a dynamic group of individuals with diverse strengths working together to continuously deliver solutions to meet the needs of our production customers. 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 passionate people with a positive mental attitude who can interact with ease within and outside our team to develop and deliver win-win solutions. The Manufacturing Engineer hired for this positon will be working with the Process Remediation team conducting process validation and verification work and remediating our documentation for existing products. 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 instrumental to success.
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 2 week “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 up to 3 years as an Engineer in a related field.
• 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.