Lead Device Development Engineer, Parenteral Systems

Viking Therapeutics, Inc.; California; On-site; USD 150,000 - 190,000; Full time

Job summary

Viking Therapeutics, Inc. seeks an Engineer of Device Development to own the integrated device development roadmap across the pipeline, partnering with CMC, Drug Product, Analytical Development, Quality, Regulatory Affairs, Clinical, and Supply Chain to deliver device components of parenteral products.

The role executes design control, risk management, verification testing, and DHF content while guiding external partners and ensuring alignment with FDA guidance and ISO standards for VK2735 and

Qualifications

• B.S. in Mechanical Engineering, Biomedical Engineering, or related field with 10+ years of device development experience; M.S. with 8+ years acceptable.
• Direct, hands-on experience with parenteral drug-device combinations under formal design control.
• Strong knowledge of device regulations and standards (21 CFR Part 4, 21 CFR Part 820, ISO 13485, ISO 14971, ISO 11608, ISO 11040).
• Experience with design verification, test method development, validation, and DHF documentation.
• Ability to lead cross-functional teams and manage external suppliers and CMOs.

Responsibilities

• Serve as the day-to-day technical lead for device and combination product workstreams.
• Execute design control deliverables per 21 CFR Part 820 and ISO 13485.
• Develop and review risk management files per ISO 14971, including FMEAs and risk controls.
• Plan and execute design verification testing and develop validation methods.
• Lead or support root cause investigations and CAPAs for device performance issues.
• Oversee external partners' technical and quality performance and supplier qualification.
• Lead design transfer, technology transfer, and manufacturing readiness activities.
• Support human factors/usability studies and instructions for use.
• Contribute to regulatory submissions and responses with Regulatory Affairs.

Skills

Design control leadership

Regulatory knowledge (21 CFR Part 4/ C

Statistical analysis

First-principles modeling

Cross-functional leadership

Project management

Education

Bachelor's in Mechanical or Biomedical Engineering

MS in related field (preferred)

Tools

JMP

Minitab

Job description

Viking Therapeutics, Inc. seeks an Engineer of Device Development to own the integrated device development roadmap across the pipeline, partnering with CMC, Drug Product, Analytical Development, Quality, Regulatory Affairs, Clinical, and Supply Chain to deliver device components of parenteral products.

The role executes design control, risk management, verification testing, and DHF content while guiding external partners and ensuring alignment with FDA guidance and ISO standards for VK2735 and