You are responsible for
Manufacturing Engineers also serve as leaders of our process technicians and therefore, we seek people who enjoy working with and developing others.
Daily sustaining work includes troubleshooting and developing solutions for various processes that vary from very simple processes, to difficult manual operations, to automated machinery with HMI interfaces, all working to produce devices with a diameter not much larger than a few hairs, but more than a meter long.
Some examples of processes include overmolding machinery, laser ablation, simple mechanical machines, temperature controllers, PLC’s, HMI’s, motion controllers, packaging and sealing pouches and trays, cleaning equipment such as ultrasonic baths, and complex custom testing equipment integrated with software, and more.
Process validation and verification work is frequently required knowledge of Master Validation Plans, IQ, OQ, PQ, Software validation, test method validation, gage R&R, a clear understanding of FDA’s QSR and cGMP, and a good grounding in statistics is instrumental to success.
Our team uses the Agile Scrum methodology to set the course of our biweekly 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, 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.
The results of your efforts in technical and process innovation will help manufacture disposable medical devices that save lives and limbs!
You are a part of
A leading health technology company with a multinational workforce of approximately 77,000 employees and globally present with sales and services in more than 100 countries worldwide.
To succeed in this role, you should have the following skills and experience
Good English Skills are necessary.
Four-year graduated engineering career required. Mechanical, Electrical, Mechatronics, Biomedical or Chemical Engineering preferred.
Typical experience required is 3-6 years as an Engineer in a related field. Medical Device experience preferred.
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.