Biomerics Plastics in Athens, Texas is looking to solve the problem of successfully launching new medical device products into production by leading the engineering team in New Product Introduction (NPI) and New Product Development (NPD) activities, focusing on technology transfer, process development, and validation of manufacturing processes.
Requirements
- Demonstrated experience leading NPI/NPD and process validation projects (IQ/OQ/PQ).
- Strong understanding of GMP, ISO 13485, and FDA QSR requirements.
- Proficient in project management, documentation systems, and technical report writing.
- Knowledge of polymer processing, injection molding, or extrusion is a plus.
- Minimum 5–7 years of experience in medical device manufacturing or a regulated industry.
Responsibilities
- Manage and execute tech transfer activities from customer or design sites to production.
- Oversee the development, qualification, and validation of manufacturing processes for medical devices in compliance with ISO 13485 and FDA regulations.
- Coordinate new product introduction activities, including tooling, equipment specification, process capability studies, and documentation control.
- Ensure the engineering team maintains proper documentation practices, including validation protocols, reports, engineering change notices, and device history records.
- Partner with Quality, Manufacturing, and Supply Chain teams to ensure robust process performance and smooth transition to full-scale production.
- Drive project schedules to meet customer and organizational milestones.
- Support quotation activities by providing engineering input on project scope, timeline, and cost estimates for new opportunities.
Other
- Lead, develop, and mentor a team of engineers and technicians focused on NPI/NPD activities.
- Collaborate with customers and cross-functional teams to define project scope, design for manufacturability, and ensure successful project execution.
- Promote a culture of continuous improvement, problem-solving, and operational excellence within the engineering function.
- Proven leadership and people management skills with experience building and developing technical teams.
- Excellent communication and customer engagement skills.
- Bachelor’s degree in Engineering (Mechanical, Manufacturing, Biomedical, or related discipline prefered).
- Please, No Recruitment Agency calls or emails (we are not using recruitment services for this or any other role posted).
