Process Development Engineer II

Description

About us:

For over three decades, Cirtec Medical has been a leading outsourcing partner for complex medical devices. We specialize in providing comprehensive solutions for Class II and III devices, from design and development to precision components and finished device assembly. Our expertise spans neuromodulation, implantable drug delivery, cardiac rhythm management, structural heart, mechanical circulatory support, and minimally invasive surgical systems. Our dedicated teams prioritize growth, innovation, and collaboration. We actively seek opportunities for improvement to enhance our support for clients. If you embrace a growth mindset and thrive on challenges, you may be a perfect fit for our team!

Position Summary:

The Engineer II - Process Development is responsible for designing, developing, and qualifying manufacturing processes for medical devices. This role supports new product development and modifications to existing products, including prototyping, process development, design verification, clinical builds, process validation, and manufacturing transfer. The position works cross-functionally with Engineering, Quality, Operations, Program Management, and customers to ensure manufacturing processes meet technical requirements, project timelines, quality standards, and regulatory expectations.

Key Responsibilities:

Design, develop, document, and qualify manufacturing processes for new and existing medical-device products.

Support product development activities, including feasibility studies, prototyping, process optimization, design verification, clinical builds, and manufacturing transfer.

Serve as the primary customer contact for low- to moderate-complexity programs and provide support on more complex projects.

Participate in and coordinate project meetings to review development activities, technical challenges, project milestones, and deliverables.

Collaborate with Program Management to develop and maintain project plans, track action items, monitor budgets, and ensure project timelines are met.

Assist in preparing customer proposals, quotations, and technical documentation while addressing customer inquiries and project requirements.

Lead or support feasibility builds, engineering testing, root cause investigations, and technical documentation.

Support equipment selection, qualification, and implementation to ensure manufacturing processes meet performance and quality requirements.

Develop manufacturing processes, work... For full info follow application link.

Cirtec Medical Corporation considers everyone for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all its related companies fully endorse equal opportunity. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.