Manufacturing Process Specialist
We are seeking a talented Manufacturing Process Specialist to join our team, specializing in moving into manufacturing within the medical device space. This role is ideal for individuals eager to oversee quality, operations, and component utilization while ensuring smooth ramp-up in manufacturing.
Job Summary:
* Lead and manage new product introduction (NPI) projects from early-stage concept through to production ramp-up by developing and optimizing manufacturing processes, ensuring scalability, cost-effectiveness, and compliance with quality standards.
Key Responsibilities:
1. Collaborate with design, quality, and manufacturing teams to ensure robust product and process development.
2. Prepare validation plans, risk assessments, and design transfer documentation.
3. Work cross-functionally to support design for manufacturability (DFM) and continuous improvement initiatives.
4. Act as liaison between R&D and manufacturing for technology transfer and pilot builds.
Requirements:
* Degree in Engineering (Mechanical, Biomedical, Manufacturing or related discipline).
* 3+ years of experience in a regulated manufacturing or product development environment (ideally medical devices, pharma, or automotive).
* Experience in NPI, process development, or design transfer projects.
* Strong understanding of validation protocols (IQ/OQ/PQ), risk management, and quality systems (ISO 13485/FDA).
* Excellent communication and project coordination skills.
Benefits:
* Opportunity to work on high-impact projects.
* Collaborative team environment.
* Professional growth and development opportunities.