You are responsible for
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 eliminate unplanned equipment downtime.
The equipment onsite varies from the very simple 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.
Daily sustaining work includes troubleshooting and developing solutions for various mechanical issues, especially with respect to the following : over molding machinery, laser ablation, simple mechanical machines, temperature controllers, PLC’s, HMI’s, motion controllers, packaging and sealing equipment, cleaning equipment such as ultrasonic baths, and complex testing equipment integrated with software, and more
The Lean Equipment Engineer and team will own preventive and corrective maintenance and Installation Qualification process validation, so knowledge of Process Validation Plans, IQ, and a clear understanding of FDA’s QSR and cGMP with respect to the requirements for equipment maintenance and documentation of maintenance records are instrumental to success.
A basic understanding of OQ, PQ, Software validation, test method validation, gage R&R, and a good grounding in statistics are helpful.
We are looking for analytical, data-based, 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! 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 technical degree required, preferably in Engineering. Mechanical, Electrical or Equipment Engineering, Maintenance Management preferred.
Typical experience required is 3-6 years as an Engineer in a related field.
Medical Device experience preferred.
Experience with Total Productive Maintenance 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.