Job Description

Summary

An innovative biotech company developing a breakthrough drug delivery platform is seeking a Director of Design and Process Engineering. This is a hands-on leadership role in a fast-paced, R&D-focused environment. You’ll lead multidisciplinary engineering efforts from early-stage design through scalable, and compliant manufacturing —driving the transition from concept to commercial product.

This is a fully on-site position.

Responsibilities

• Lead design and development of mechanical, fluidic, and material systems for drug delivery
• Manage and mentor a cross-functional engineering team
• Develop and execute product design, prototyping, and process scale-up strategies
• Oversee CAD modeling, materials selection, and mechanical validation
• Design and implement scalable manufacturing processes for clinical and commercial use
• Ensure compliance with FDA, ISO 13485, and other regulatory standards
• Drive risk management (e.g. FMEA), design controls, and testing plans (bench, in-vitro, in-vivo)
• Collaborate with formulation scientists and cross-functional stakeholders

Qualifications

• MS or PhD in Mechanical Engineering, Biomedical Engineering, or related field
• 10+ years in medical device or drug delivery development
• Proven track record in early-stage design and process engineering
• Proficient in CAD (SolidWorks/Creo) and simulation tools (COMSOL/Ansys)
• Strong knowledge of biomaterials, polymers, and drug-device interfaces
• Experience in startup or fast-paced R&D environments preferred
• Familiarity with ingestible, implantable, or oral delivery systems is a plus

Please note that we cannot support visa transfers or sponsorship at this time.

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