Engineer, Device Development

Viking Therapeutics, Inc.•San Diego, CA

2d•$190,000 - $215,000

About The Position

The Engineer, Device Development combines hands-on technical execution with ownership of the integrated device development roadmap across Viking Therapeutics’ pipeline. The position is part of Technical Operations and works with internal Chemistry, Manufacturing and Controls (CMC), Drug Product, Analytical Development, Quality, Regulatory Affairs, Clinical, and Supply Chain teams. It 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 develops device constituent parts for parenteral combination products, including prefilled syringes, autoinjectors, and pen injectors. Work includes design controls, risk management, design verification testing, test method development and validation, and engineering characterization, applying first-principles analysis to device performance and drug-device interactions. The Engineer contributes device content to the Design History File (DHF), CMC documentation, and regulatory submissions for VK2735 and other metabolic and endocrine disorder pipeline assets. In addition to leading assigned workstreams, the Engineer owns roadmap planning, platform strategy, lifecycle planning, milestones, resource forecasts, and proposed budgets. The role leads cross-functional governance and stage-gate reviews, supports partner selection and oversight, and builds device development capabilities through procedures, technical standards, and mentoring. The position requires 15–20% domestic and international travel to device suppliers, test laboratories, and manufacturing sites.

Requirements

B.S. in Mechanical Engineering, Biomedical Engineering, or a related engineering field with 10 or more years of relevant experience; or an M.S. in one of these fields with 8 or more years of relevant experience; or an equivalent combination of education and experience.
Direct, hands-on experience developing parenteral drug-device combination products such as prefilled syringes, autoinjectors, or pen injectors under formal design control processes.
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 ability to build first-principles models of device performance.
Proficiency with statistical analysis tools such as JMP or Minitab and statistical methods 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.
Experience 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.
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 approach, with ability to manage competing priorities and external partners in a fast-paced, lean biotech environment.
Ability to travel 15–20% domestically and internationally to suppliers, test laboratories, and manufacturing sites.

Nice To Haves

Experience with finite element analysis.
Experience authoring device content for regulatory submissions.
Familiarity with peptide or biologic drug product interactions with primary container components, such as siliconization and container closure integrity, and associated cold-chain considerations.
Experience with GLP-1/GIP or other peptide combination products.
Prior experience contributing to formative or summative human factors/usability studies.
Experience supporting a program through clinical or commercial launch.

Responsibilities

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 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-control verification and validation evidence.
Plan and execute design verification testing; develop, validate, and transfer physical test methods for device functionality, consistent with applicable ISO 11608 and ISO 11040 requirements.
Apply first-principles engineering analysis and modeling, including fluid dynamics, solid mechanics, and finite element analysis, to characterize injection force and injection time and assess relevant formulation, component, and environmental sensitivities.
Develop statistically sound test strategies and test matrices 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 disposition of engineering changes, non-conformances, deviations, and CAPAs.
Support human factors and usability engineering, including use-related risk analysis, formative studies, summative studies, and instructions for use.
Oversee external partners’ technical and quality performance and provide 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 PPQ campaigns; serve as Person-in-Plant during key campaigns as needed.
Partner with Analytical Development on primary container closure selection and drug-device compatibility, including CCI, extractables and leachables, biocompatibility, and shipping and transit evaluations.
Author and review device and combination product technical content for regulatory submissions, and support responses to health authority questions with Regulatory Affairs.
Manage timelines, deliverables, and technical risks for assigned workstreams; communicate status and escalate 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 platform strategy, lifecycle planning, milestones, dependencies, and technical decision criteria.
Lead cross-functional device governance and stage-gate reviews, resolve 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 resources.
Lead technical partner selection and governance with Quality, Supply Chain, and other stakeholders; establish scopes of work, deliverables, performance expectations, and escalation processes.
Integrate design control, risk management, verification and validation, human factors, design transfer, and manufacturing readiness strategies into a coordinated approach aligned with Quality and Regulatory Affairs.
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 colleagues, and guiding consultants and external technical teams.
Perform other duties as assigned.