Senior Medical Device Engineer & Development Leader

Lupin Ltd; Town of Florida (NY); On-site; USD 120,000 - 170,000; Full time

Benefits offered by this job

Equal opportunity employer

Affirmative action employer

Job summary

Lupin Inc. in Coral Springs, FL, is seeking experienced professionals to lead the development and manufacturing of medical devices and drug/device combinations. You will drive design, testing, and documentation across a cross-functional team to meet regulatory and quality standards.

The role emphasizes device design concepts, materials selection, risk management, and DHF development, with opportunities to support Health Authority interactions and ongoing process improvements.

Qualifications

• Minimum: relevant degree in Engineering and at least 5 years experience in a similar area with continuing education (EU) or BSc or equivalent.
• Highly Desirable: MSc or equivalent and at least 5 years in medical device/pharma development.
• Prior experience with dry powder inhalers, MDI, nasal sprays, nebulizers desired.
• Experience with Design Control and Design History Files.
• Proficiency with SolidWorks or CAD tools and metrology equipment.

Responsibilities

• Provide device and primary packaging expertise across drug product development, leading and coordinating device components and assemblies in compliance with standards.
• Lead strategies for device material selection, design concepts, cost reduction, high-volume manufacturing and process improvements.
• Collaborate with internal and external partners, monitor progress, support and challenge technical development.
• Define product requirements for medical devices and drug/device combinations, plan studies, and report results.
• Develop robust devices/processes for medical devices/combination products and manage risk, documentation and DHFs.
• Lead and monitor DHF development and human factors studies; support regulatory activities with Health Authorities.
• Coach team members and contribute to project strategies and goals.

Job description

Lupin Inc. in Coral Springs, FL, is seeking experienced professionals to lead the development and manufacturing of medical devices and drug/device combinations. You will drive design, testing, and documentation across a cross-functional team to meet regulatory and quality standards.

The role emphasizes device design concepts, materials selection, risk management, and DHF development, with opportunities to support Health Authority interactions and ongoing process improvements.