Senior Manufacturing Engineer Role Overview
We are seeking a Senior Manufacturing Engineer to lead manufacturing and process development for our latest device—a pioneering technology that enables cancer care in the home.
This role offers the opportunity to be part of a rapidly scaling organization, working at the intersection of R&D, Quality, Design Assurance, and Operations to bring life-changing technologies to patients.
* Impactful Work: Contribute to the development and delivery of high-impact medical devices that make a real difference to patients.
* Growth Opportunities: Comprehensive training and continuous personal and professional development are embedded in our culture.
* Flexibility and Benefits: A competitive salary, strong benefits package, flexible working hours, and a generous vacation policy are all part of the offer.
Key Responsibilities:
* Collaborate with R&D on optimizing product designs for manufacturability (DFM) and assembly (DFA).
* Establish and validate a new assembly line within a Class 8 cleanroom, including jig and fixture design.
* Lead equipment and process validation for device assembly.
* Support builds for R&D testing, product verification, validation, clinical trials, and commercial launch.
* Develop robust work instructions, test methods, and process controls.
* Drive root cause investigations and resolve process non-conformances.
* Manage timelines for manufacturing projects and coordinate with external suppliers.
* Continuously identify and implement manufacturing process improvements.
* Utilize CAD tools and in-house prototyping equipment to design and refine fixtures.
* Ensure delivery of projects on time, on cost, and to quality standards.