layiq

/la·yiq/adjective

worthy; deserving; fitting; suitable.

A role, opportunity, or path that merits attention, time, and pursuit.

LAYIQ - Senior Engineer/Manager, Device Development — Combination Products at Oruka Therapeutics

Device Technical Leadership
Serve as the day-to-day technical lead for one or more assigned combination device programs (autoinjector, prefilled-syringe-based, or on-body/wearable injector systems).
Execute device design control deliverables: design inputs/outputs, Design History File (DHF) content, verification and validation protocols/reports, and risk management files per ISO 14971.
Support human factors and usability engineering activities per IEC 62366-1 and FDA guidance, planning and running formative studies and supporting summative (validation) studies led by HFE/the Associate Director.
Execute device platform standardization initiatives, evaluating component and process options at the program level.
Review and disposition device engineering changes, non-conformances, and CAPAs for assigned programs.
Program & Project Management
Own program timelines, budgets, and risk registers for assigned device development workstreams.
Drive stage-gate deliverables and readiness reviews for assigned programs, in partnership with Combination Product and Program Management.
Manage cross-functional project plans, track critical path, and flag schedule or technical risks to the Associate Director/Director.
Report program status and risks in team and program reviews.
External Supplier, Vendor & CDMO Management
Support selection and qualification of device component suppliers and device CDMOs/CMOs
Own the day-to-day, working-level technical relationship with external partners — technical oversight of device design, tooling, process development, and scale-up execution.
Support negotiation and administration of quality agreements, technical agreements, and statements of work.
Execute technology transfer activities from development through commercial manufacturing, escalating strategic decisions as needed.
Track supplier performance and quality metrics day to day and drive resolution of routine technical or quality issues.
MSAT & Manufacturing Support
Provide MSAT leadership for clinical and commercial device and combination-product manufacturing, including engineering, clinical, PPQ, and commercial campaigns.
Serve as Person-in-Plant, providing on-site technical oversight and rapid issue resolution.
Partner with CMOs and internal teams to lead technology transfer, scale-up, investigations, deviations, CAPAs, and continuous process improvement.
Cross-Functional & Regulatory Collaboration
Partner with Quality, Regulatory Affairs, CMC/Drug Product, Clinical Supply, and Supply Chain on device-related deliverables for assigned programs.
Author and support device-related content for combination product regulatory submissions (IND, NDA/BLA, design dossiers).
Support Commercial and Marketing on device user needs and post-launch lifecycle activities for assigned programs.

Senior Engineer/Manager, Device Development — Combination Products

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