Job Description

Director, Design & Process Engineering

Location: San Diego, California - On site

Department: Technical Operations

Reports To: VP, Technical Operations

JOB DESCRIPTION

Our medical device client is seeking a Director of Design and Process Engineering to lead development of a novel drug delivery platform. This is a hands-on leadership role in a research-focused startup, which will be pivotal in scaling early-stage development into manufacturable, regulatory-compliant, commercial products.

The successful candidate will oversee end-to-end product design, process development, and integration with pharmaceutical formulation, working closely with a multi-disciplinary engineering team and across all functional groups at the company.

RESPONSIBILITIES

Leadership & Strategy

• Lead the design and engineering development of advanced drug delivery systems, focusing on mechanical, fluidic, and material aspects
• Define engineering roadmaps aligned with business goals and commercialization strategy
• Mentor and manage a multidisciplinary engineering team
• Represent engineering in external partnerships and potential pharma collaborations
• Oversee mechanical sub-systems and system-level design from concept to prototype, including CAD modeling, FEA, materials selection, and design validation
• Guide integration of microfabricated components, mechanical actuation systems, and oral delivery form factors
• Lead the establishment of product requirements and aligned mechanical engineering specifications
• Collaborate with systems engineering to ensure user-centered and clinically appropriate design principles are applied
• Design and validate scalable manufacturing processes
• Collaborate with formulation scientists to ensure robust drug-device interface compatibility
• Together with the test engineering team, develop test plans (bench, in-vitro, in-vivo) and oversee device reliability, safety, and performance testing
• Lead risk assessments (e.g., FMEA) and design controls documentation on behalf of design and process engineering

EDUCATION & EXPERIENCE

• MS or PhD in Mechanical Engineering, Biomedical Engineering, or a related field
• 10+ years of experience in medical device development or drug delivery systems
• Proven track record in early-stage device design and process development
• Experience in startups or fast-paced R&D environments preferred
• Familiarity with oral delivery systems, drug-device combination products, or ingestible or implantable devices is a strong plus

CAPABILITIES & SKILLS

• Strong CAD (SolidWorks/Creo), simulation (COMSOL/Ansys), and prototyping skills
• Knowledge of biomaterials, polymers, and drug release mechanisms
• Excellent communication, leadership, and organizational abilities
• Entrepreneurial mindset with a passion for innovative healthcare solutions

Job Tags

Similar Jobs