Engineer, Device Development

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

The Engineer of Device Development combines hands-on technical execution with ownership of the integrated device development roadmap across Viking Therapeutics’ pipeline, including platform strategy, lifecycle planning, resource forecasts, and proposed budgets. Within Technical Operations, the Engineer partners with internal Chemistry, Manufacturing and Controls (CMC), Drug Product, Analytical Development, Quality, Regulatory Affairs, Clinical, and Supply Chain teams and serves as the day-to-day technical interface with external device suppliers, component vendors, test laboratories, contract manufacturing organizations (CMOs), and contract development and manufacturing organizations (CDMOs). The role executes design control deliverables, risk management, design verification testing, test method development and validation, and engineering characterization for device constituent parts of parenteral combination products, such as prefilled syringes, autoinjectors, and pen injectors. This work applies first-principles engineering analysis to device performance and drug-device interactions. The Engineer contributes device content to the Design History File (DHF), CMC documentation, and regulatory submissions supporting Viking’s lead GLP-1/GIP dual agonist program (VK2735) and additional metabolic and endocrine disorder pipeline assets.

ESSENTIAL DUTIES AND RESPONSIBILITIES

The main responsibilities of this role include:

• Serve as the day-to-day technical lead for assigned device and combination product workstreams.

• Execute design control deliverables in accordance with 21 CFR Part 820 (QMSR) and ISO 13485, including user needs, design inputs and outputs, requirements traceability, design review materials, and Design History File (DHF) content.
• Author and maintain device and combination product risk management files in accordance with ISO 14971, including hazard analyses, design, process, and use FMEAs, and traceability of risk controls verification and validation evidence.
• Plan and execute design verification testing, and develop, validate, and transfer physical test methods for device functionality, such as break-loose and glide force, injection time, delivered volume, activation force, and needle extension, consistent with ISO 11608 and ISO 11040 as applicable.
• Apply first-principles engineering analysis and modeling (e.g., fluid dynamics, solid mechanics, finite element analysis) to characterize injection force and injection time, and evaluate sensitivity to formulation viscosity, primary container dimensions, siliconization, needle gauge, fill volume, and temperature.
• Develop statistically sound test strategies and test matrices (e.g., sample size justification, tolerance intervals) to establish design robustness, evaluate component and manufacturing variation, and support device specifications, acceptance criteria, and control strategies.
• Lead or support root cause investigations into device performance issues and out-of-trend results; review in-process and release data for trends; and support the disposition of device engineering changes, non-conformances, deviations, and CAPAs for assigned programs.
• Support human factors and usability engineering activities in accordance with applicable FDA human factors guidance, including use-related risk analysis, formative studies, support of summative (validation) studies, and instructions for use.
• Oversee external partners' technical and quality performance, including review of design, tooling, and process development and technical input to the selection and qualification of device suppliers, component vendors, test laboratories, CMOs, and CDMOs.
• Support design transfer, technology transfer, and scale-up of device assembly and combination product manufacturing, including engineering, clinical, and process performance qualification (PPQ) campaigns, and serve as Person-in-Plant during key manufacturing campaigns as needed.
• Partner with Analytical Development on primary container closure selection and drug-device compatibility, including container closure integrity (CCI), extractables and leachables, biocompatibility, and shipping and transit evaluations.
• Author and review device and combination product technical content for regulatory submissions (INDs, NDAs/BLAs, MAAs) consistent with 21 CFR Part 4 combination product cGMP requirements, and support responses to health authority questions in collaboration with Regulatory Affairs.
• Manage timelines, deliverables, and technical risks for assigned device workstreams; communicate status and elevate schedule or technical risks at integrated project team meetings and to Technical Operations leadership.

• Monitor emerging drug delivery technologies, industry standards, and regulatory guidance.

• Define and own the integrated device development roadmap across programs, including device platform strategy, lifecycle planning, key milestones, dependencies, and technical decision criteria.
• Lead cross-functional device governance and stage-gate reviews; drive resolution of technical trade-offs and present risk-based recommendations and mitigation plans to senior leadership.
• Establish device development plans, resource forecasts, and proposed budgets; manage approved spending and recommend prioritization of internal and external resources to meet program objectives.
• Lead technical partner selection and governance in collaboration with Quality, Supply Chain, and other stakeholders; establish scopes of work, deliverables, performance expectations, and escalation processes for external device partners.
• Integrate design control, risk management, verification and validation, human factors, design transfer, and manufacturing readiness strategies into a coordinated device development approach, ensuring alignment with Quality and Regulatory Affairs and accountability for timely device deliverables.
• Lead device development input to regulatory submission planning and health authority interactions in partnership with Regulatory Affairs.
• Build device development capabilities by establishing procedures and technical standards, mentoring internal colleagues, and guiding consultants and external technical teams.
• Other duties as assigned.

EDUCATION AND EXPERIENCE REQUIREMENTS

• B.S. in Mechanical Engineering, Biomedical Engineering, or a related engineering field with 10+ years of medical device and/or combination product development experience in the pharmaceutical, biotech, or medical device industry; M.S. in one of these fields with 8+ years of such experience; or an equivalent combination of education and experience.

KNOWLEDGE AND SKILLS REQUIREMENTS

• Direct, hands-on experience developing parenteral drug-device combination products (e.g., prefilled syringes, autoinjectors, pen injectors) under formal design control processes, with demonstrated ability to lead complex device development decisions across functions and external organizations while balancing technical risk, patient needs, quality, timelines, and cost.
• Working knowledge of combination product and device regulations and standards, including 21 CFR Part 4, 21 CFR Part 820, ISO 13485, ISO 14971, IEC 62366-1, ISO 11608, ISO 11040, and ISO 10993.
• Hands-on experience with design verification testing, test method development and validation, and component qualification.
• Strong engineering fundamentals in solid mechanics, fluid dynamics, and systems design, with the ability to build first-principles models of device performance; experience with finite element analysis is a plus.
• Proficiency with statistical analysis tools (e.g., JMP, Minitab) and statistical methods for medical devices, including sample size determination, tolerance interval analysis, and measurement system analysis.
• Experience forecasting resource and budget needs and building scalable technical capabilities in a lean development organization.
• Overseeing external device suppliers, test laboratories, CMOs, and/or CDMOs, with accountability for technical execution, tooling, process development, or manufacturing scale-up.
• Strong technical writing skills, including protocols, reports, and DHF documentation; experience authoring device content for regulatory submissions is a plus.
• Familiarity with peptide or biologic drug product interactions with primary container components (e.g., siliconization, container closure integrity) and associated cold-chain considerations; experience with GLP-1/GIP or other peptide combination products is a plus.
• Prior experience contributing to human factors/usability studies (formative or summative) and supporting a program through clinical or commercial launch is a plus.
• Ability to lead cross-functional, matrixed teams without direct authority and translate portfolio and product objectives into device strategies, investment recommendations, and actionable plans.
• Strong communication and project management skills, including presenting strategies, key risks, and recommendations to senior leadership and representing device development in governance discussions.
• Entrepreneurial, hands-on, organized, and detail-oriented, with the ability to manage competing priorities and external partners in a fast‑paced, lean biotech environment.
• Requires 15-20% domestic and international travel to device suppliers, test labs, and manufacturing sites.