Job Title: Process Development Engineer
Company Overview:
We are a medical device company developing innovative heart support devices to help interventional cardiologists stabilize patients in acute heart failure or during high-risk coronary procedures.
Our Objective: To overcome the limitations of current assist devices by providing a more effective and less invasive solution.
About Us:
We were founded in 2018 as a spin-off from Radboud UMC. Our team consists of enthusiastic individuals with diverse backgrounds and expertise located in the Netherlands and Ireland.
Job Description:
* Support the development and implementation of manufacturing processes for our pVAD catheter, including design feedback & input, and working with suppliers of catheter components.
* Collaborate closely with counterparts responsible for device development and characterization, other development functions, and Quality to realize full potential.
* Develop entrepreneurial spirit, persistence, and resourcefulness to succeed in a start-up environment.
* Work in a self-directed manner, leveraging hands-on knowledge and experience in cardiovascular device development and manufacturing processes.
Responsibilities:
* Develop manufacturing processes, materials, and methods within the product development team, utilizing both in-house and external development paths.
* Design, specify, procure, and qualify process fixtures and equipment.
* Develop Work Instructions and supporting documentation (e.g., calibration and maintenance) for manufacturing processes.
* Execute process characterisation and validation activities.
* Provide technical guidance to team members on assembly and manufacture of products.
* Maintain compliance with quality requirements and ensure Quality is integrated into all aspects of work.
* Collaborate with internal cross-functional teams and contract manufacturers/design firms to ensure system design meets design input.
* Evaluate relevant process & manufacturing technologies and identify opportunities to implement them strategically.
* Manage project plans, tasks, and deliverables, meeting project deadlines through structured problem-solving techniques and statistical methods.
Requirements:
* Minimum three years' experience in medical device development, with either a primary or Master's Degree in an engineering discipline such as polymer, mechanical, manufacturing, or biomedical engineering.
* Experience in fabrication and manufacture of catheter-based medical devices; large calibre delivery systems advantageous.
* Product and process development skills, new product introduction in medical devices necessary: fixture and equipment design & specification, validation of processes and process equipment, Work Instructions and Calibration & Maintenance activities for manufacturing processes.
Career Opportunities:
This role presents a chance to be part of a dynamic team shaping the future of heart support devices and contributing to life-changing innovations.
Contact Information:
For more information, please forward your application or contact us at [phone number].