Director, Design & Process Engineering

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