The Process Engineer is responsible for supporting existing product lines to ensure safety, compliance and product availability. In addition, provide engineering support to manufacturing for transition of new products and scale-up for production. Medical Device Experience or Life Sciences Experience is preferred.
Design and develop tooling and fixtures to effectively manufacture new products.
Troubleshoot equipment and procedures.
Create and maintain the documentation necessary to ensure the consistent manufacture of neurovascular products (processes, drawings and shop floor paperwork).
Maintain current production processes and assist in smooth transfer of new processes onto the production line.
Develop and execute process characterization, validation and material qualification plans.
Apply fundamental engineering principles to create practical solutions to technical challenges and provide technical support across functions.
Assist in the transfer of newly developed products from R&D to Production.
Writing and executing protocol and test reports.
Education + Experience
Master's or Bachelor s degree (Mechanical, biomedical or related technical field).
Minimum of 2 years of professional, related engineering experience.
Process automation experience strongly preferred.
Extensive experience in equipment design and validation specifically with processes related to disposable catheter systems.
Plant/Manufacturing transfer experience - preferred.
Minimum of 2 years in a medical device manufacturing / process development role.