Biomerics
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Engineering Manager, New Product Introduction
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Biomerics .
Company Overview 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 focus on next‑generation solutions for vascular access, electrophysiology, cardiac rhythm management, neurovascular, structural heart, and cardiovascular markets.
Job Type Full‑time
Job Description The Engineering Manager for Biomerics Plastics in Athens, Texas leads 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.
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.
Requirements
Bachelor’s degree in Engineering (Mechanical, Manufacturing, Biomedical, or related discipline preferred).
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.
Knowledge of polymer processing, injection molding, or extrusion is a plus.
Benefits Medical, Dental, and Vision insurance; Short‑Term and Long‑Term Disability; Life Insurance; Paid Vacation Days; Paid Holidays; and 401(k).
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Engineering Manager, New Product Introduction
role at
Biomerics .
Company Overview 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 focus on next‑generation solutions for vascular access, electrophysiology, cardiac rhythm management, neurovascular, structural heart, and cardiovascular markets.
Job Type Full‑time
Job Description The Engineering Manager for Biomerics Plastics in Athens, Texas leads 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.
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.
Requirements
Bachelor’s degree in Engineering (Mechanical, Manufacturing, Biomedical, or related discipline preferred).
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.
Knowledge of polymer processing, injection molding, or extrusion is a plus.
Benefits Medical, Dental, and Vision insurance; Short‑Term and Long‑Term Disability; Life Insurance; Paid Vacation Days; Paid Holidays; and 401(k).
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