Duration: 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.
Our daily work includes both sustaining and project work – we strive to complete the types of projects that remove the need for sustaining work – improving safety, quality, output and eliminating scrap.
Daily sustaining work includes troubleshooting and developing solutions for various electrical, chemical, mechanical, materials science, optics, high vacuum, and laser issues. Ability to perform complex modeling in SolidWorks is required. Equipment troubleshooting and repair – simple mechanical machines, temperature controllers, PLC’s, HMI’s, motion controllers, etc.; ultrasonic cleaning; verification testing – joulemeter, residual gas analysis, transmission spectroscopy, etc.
Process verification and validation is frequently required for project work – knowledge of Master Validation Plans, Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), Software validation, test method validation, Gage R&R, when verification is appropriate vs. validation for capital equipment, a clear understanding of FDA’s QSR and cGMP ,and a good grounding in statistics are instrumental to success.
Frequently we must dig deep into problems to fully understand root cause and implement solutions that will prevent re occurrence. The manufacturing engineer will be expected to organize investigations, pursue a logical course of inquiry, be able to collect and analyze data and see patterns/trends, design controlled experiments and analyze the results of those experiments to make rational conclusions about courses of action, and document findings clearly and appropriately.
Our manufacturing engineering team is also leaning in heavily to the application of Lean, Six Sigma and DMAIC to our production processes. We highly value engineers who are able to use process thinking and lean tools to develop standard work, eliminate waste at the bottlenecks and simultaneously increase productivity, quality, safety while lowering costs.
Our team uses the Agile Scrum methodology to set the course of our weekly work. Together with our production customers, we prioritize the highest value solutions from our storehouse of improvement ideas and 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 delivering just what the customer wants. We care deeply about our customers, both internal and external, and strive to continuously improve our products and processes. 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.
Strong Technical Writing Skills are highly desired
Strong ability to partner cross functionally - particularly with Quality Engineering, Supplier Quality Engineering, Buyers, Regulatory and Production is critical.
An understanding of process validation/verification relating to medical device regulations is preferred.
A demonstrated ability to plan and run projects is highly desired.