Lead Device Development Engineer Parenteral Combos

Viking Therapeutics; San Diego (CA); On-site; USD 190,000 - 215,000; Full time

Job summary

Viking Therapeutics in San Diego seeks an Engineer of Development to own the device development roadmap for parenteral products, collaborating with CMC, Analytical Development, Regulatory Affairs, and Quality to deliver design control, risk management, and verification activities.

You will lead cross-functional workstreams, manage external partners, and contribute to regulatory submissions while applying first-principles engineering to optimize device performance and patient outcomes.

Qualifications

• Direct hands-on experience with parenteral drug-device products under design control.
• Strong knowledge of 21 CFR Part 4/820, ISO 13485, ISO 14971 and related standards.
• Ability to lead cross-functional teams and external partners.

Responsibilities

• Lead device workstreams and manage technical risks across programs.
• Plan and execute design verification testing and validation activities.
• Oversee external suppliers, CMOs/CDMOs, and tooling for device development.
• Support human factors/usability studies and regulatory submissions.

Skills

Device development

Cross-functional leadership

Regulatory standards

FEM analysis

Statistical methods

Education

Engineering degree (B.S./M.S.)

Tools

JMP

Minitab

Job description

Viking Therapeutics in San Diego seeks an Engineer of Development to own the device development roadmap for parenteral products, collaborating with CMC, Analytical Development, Regulatory Affairs, and Quality to deliver design control, risk management, and verification activities.

You will lead cross-functional workstreams, manage external partners, and contribute to regulatory submissions while applying first-principles engineering to optimize device performance and patient outcomes.