Engineering Manager - New Product Development

Biomerics•Athens, TX

About The Position

Biomerics is a world-class manufacturer and innovative polymer solutions provider for the medical device and biotech industries. As a vertically integrated company, we specialize in designing, developing, and producing medical devices for diagnostic and interventional procedures. We are focused on next-generation solutions for vascular access, electrophysiology, cardiac rhythm management, neurovascular, structural heart, and cardiovascular markets. At Biomerics, we are dedicated to our diverse employee base. We understand that a strong, skilled, and engaged workforce is the foundation of our continued success as a business. We strive to live up to the Biomerics values in all our interactions. It is an exciting time to be part of our collective team, and there is no limit to the impact that can be achieved here at Biomerics. We improve and advance our employees' lives and the lives of the patients who depend on our products. At Biomerics, we are guided by our core values of integrity, partnership, empowerment & accountability, trust, agility, teamwork, and excellence. We deeply care about our team members and customers, and our team-oriented, customer-focused corporate culture places a premium on building strategic, mutually beneficial partnerships. Joining our team means becoming part of a dynamic, innovative, and caring community. Position Summary The Engineering Manager for Biomerics Plastics in Athens, Texas is responsible for leading the engineering team supporting New Product Introduction (NPI) and New Product Development (NPD) activities. This role focuses on technology transfer, process development, and validation of medical device manufacturing processes to ensure new products are successfully launched into production. The Engineering Manager drives engineering excellence by ensuring proper documentation, compliance with quality standards, and alignment with customer and regulatory requirements.

Requirements

Bachelor’s degree in Engineering (Mechanical, Manufacturing, Biomedical, or related discipline prefered).
Minimum 5–7 years of experience in medical device manufacturing or a regulated industry.
Demonstrated experience leading NPI/NPD and process validation projects (IQ/OQ/PQ).
Strong understanding of GMP, ISO 13485, and FDA QSR requirements.
Proven leadership and people management skills with experience building and developing technical teams.
Excellent communication and customer engagement skills.
Proficient in project management, documentation systems, and technical report writing.

Nice To Haves

Knowledge of polymer processing, injection molding, or extrusion is a plus.

Responsibilities

Lead, develop, and mentor a team of engineers and technicians focused on NPI/NPD activities.
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.
Collaborate with customers and cross-functional teams to define project scope, design for manufacturability, and ensure successful project execution.
Coordinate new product introduction activities, including tooling, equipment specification, process capability studies, and documentation control.
Drive project schedules to meet customer and organizational milestones.
Ensure the engineering team maintains proper documentation practices, including validation protocols, reports, engineering change notices, and device history records.
Support quotation activities by providing engineering input on project scope, timeline, and cost estimates for new opportunities.
Partner with Quality, Manufacturing, and Supply Chain teams to ensure robust process performance and smooth transition to full-scale production.
Promote a culture of continuous improvement, problem-solving, and operational excellence within the engineering function.