Director, Design & Process Engineering Job at Cypress HCM, San Diego, CA

dWN3TkM2OEY2UzNzM0lPSi9sNnFaYVk9
  • Cypress HCM
  • San Diego, CA

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

Integrity Trade Services

Warehouse Packer Job at Integrity Trade Services

 ...Job Description Job Description Warehouse Packer $16.00-$18.00 hr. DOE This is a contract position with an opportunity to be hired full-time. Integrity Trade Services is seeking a reliable and experienced Warehouse Packer to join our clients team in Houston... 

Soul Crazy

Web Designer Job at Soul Crazy

Five Top Web Apps for Your Web Design Workflow The project control software can often be difficult to install. Paymo is a challenge management web app; it allows you to manage tasks from start to finish, including project management, time tracking, and resource scheduling... 

U.S. Dermatology Partners | Clearlake, TX - U.S. Dermatology...

Dermatology - Physician Job at U.S. Dermatology Partners | Clearlake, TX - U.S. Dermatology...

 ...JOB DESCRIPTION U.S. Dermatology Partners is seeking an exceptional Board-Certified or Board-Eligible Dermatologist to join our premier dermatology practice in Clearlake, Texas ! Join a well-established, busy practice serving Houston area residents for decades! This... 

CHRISTUS Health

RN, Registered Nurse - ECC Forensic Nursing - PRN Job at CHRISTUS Health

Description Summary: The competent Nurse, in the same or similar clinical setting, practices independently and demonstrates an awareness of all relevant aspects of a situation. Provides routine and complex care, with the ability to on long-range goals or plans. Continues...

Atlantic Packaging and Converting

Printing Press Operator Job at Atlantic Packaging and Converting

 ...are a multi-faceted and stable organization. We offer quality printing for label, shrink sleeve, folding carton and commercial printing...  ...function of this position is to set up, operate, and maintain an offset or flexo press. Other duties include but are not limited to:...