Process Engineer - Medical Devices
Phillips-Medisize A/S is part of the Pharmaceutical and Medical Division of Molex, a leader in the design, development and delivery of advanced drug delivery devices and connected health solutions. To strengthen our team in Struer, we are looking for a Process Engineer to start as a soon as possible. In this role you have the possibility to take ownership over the production processes and develop the production line for new devices as well as participate in continuous improvement projects.
What You Will Do In Your Role
- Play a key role in ensuring an effective production setup and test equipment for parts, products, services, and maintenance in collaboration with the Project Team.
- In the field Process Engineering, you will be responsible for specification, development, risk analysis, test, validation and appropriate documentation of production and test setup for medical devices (NPI – New product Introduction).
- Participate in Production KPI meeting to improve quality, cost, and work environment.
- Make specification for production setup of medical devices.
- Participate in and contribute to the project with focus on integrated product development including design for manufacturing.
- Create/update work instructions, SOP´s and other production relevant documentation.
- Develop and provide appropriate and accurate information to partners within and outside of the production in terms of documentation, design review, samples, and reference items etc.
- Contribute to continuously improvement of product and production development by shearing experience, best practice and lessons learned.
- Participate in root cause analysis.
The Experience You Will Bring
- University degree in manufacturing engineering
- Experience in a similar position (e.g., Production Engineer) within a highly regulated industry
- Understanding of the importance of maintaining a high level of quality and documentation
- Proactive, result oriented and a self-motivated team player
- Strong communication skills and a structured and analytical way of working
- Ability to work independently, across functional teams and with external partners
- Fluent in English
What Will Put You Ahead
- Experience with ISO 13485, 14644-1, GAMP and other related standards in the field of medical devices
- Six Sigma Certification (Green or Black Belt)
Phillips-Medisize A/S is an expert in the design, development, and delivery of advanced drug delivery devices and connected health solutions. The customers are leading pharmaceutical companies worldwide. Phillips-Medisize A/S is a part of Phillips-Medisize the Pharmaceutical and Medical Division of Molex. The company offers innovative and integrated solutions supported by an end-to-end service offering from Strategy to Launch. Read more about Phillips-Medisize A/S at phillipsmedisize.com.