SUMMARY
A process development engineer plans, designs and executes cost-effective production systems, in order to enhance the speed and quality of processing, and ensure produced items comply with international regulations and industry standards.
Process development engineers use technical knowledge and industry expertise to review existing manufacturing production lines and plan cost-effective production processes within a business. For example, these professionals may use computer modeling software to test how new machinery or technology could improve the speed of production.
DUTIES AND RESPONSIBILITIES:
- Act as project managers and analyze new equipment, technology, or machinery to implement into the production process
- Lead and support the development of specialized catheter manufacturing techniques, including liner assembly, jacket reflow, coil winding, braiding, tipping, bonding, and other advanced processes. Ensure these technologies are robust, scalable, and aligned with product requirements.
- Design specifications for product use, create schedules for implementation, and oversee installation.
- Develop, configure and optimize processes from inception through to start up and certification
- Assess processes, take measurements and interpret data
- Design, run, test and upgrade systems and processes
- Develop best practices, routines and innovative solutions to improve production rates and quality of output
- Perform process simulations
- Manage cost and time constraints
- Perform risk assessments
- Provide process documentation and operating instructions
- Develop quality control criteria and safety guidelines and ensuring that all team members adhere to them.
- Performs other related duties as assigned by management.
Requirements
- Bachelor's degree in engineering and related fields and a minimum of 7 years of experience in process development, preferably in medical devices industry or highly regulated industries.
- English proficiency (B2, C1 equivalent)
- Good working knowledge on some or any of the following technologies braiding, reflow, grinding, adhesive bonding, and soldering processes.
- Experience in manufacturing and product transfers
- Experience in equipment qualification, process improvement and process validation
- Proven abilities to work on collaborative environments and operational excellence.
Benefits
Highly competitive package
Top Skills
What We Do
Nextern collaborates with innovators, clinicians, and device partners to create, iterate, optimize and manufacture best-in-class medical devices. We bring an unmatched core competence in medical device product design and development through manufacturing as a leverageable asset to collaborators like you, who are focused on accelerating the commercial side of the business.
.jpg)
