Design Transfer & Lifecycle Engineering Technical Manager

Description

The Design Transfer & Lifecycle Engineering (DTLE) Technical Manager is the technical steward of IMMY’s commercial LFA, EIA and molecular product portfolio. This player-coach role personally executes the highest-complexity design transfer and lifecycle engineering work, serves as the Tier 2 manufacturing floor escalation point for design-level problems, holds yes/no authority on changes that could affect product performance, and owns the technical quality of all regulated DTLE work products.

The Technical Manager also builds and manages the DTLE team as the function scales. Reporting to the Chief Operating Officer (COO), the role partners closely with Product Development, Quality, Regulatory Affairs, Process Engineering, Manufacturing, and Supply Chain.

• Driving Results: Translate company and department goals into team priorities and daily assignments.
• Fostering a Culture of Excellence: Set the standard for technical quality, documentation discipline, and accountability; champion IMMY’s Core Values and continuous improvement.

• Allocating Work and Building Capacity: Assign work by capacity and expertise, track workload across concurrent transfers and lifecycle events, and upscale constraints to the COO.
• Developing Team Members: Coach and mentor direct reports.
• Enabling Cross-Functional Execution: Keep working alignment with PD, QA, RA, PE, Make, Supply Chain, and the CMO to ensure good communication.

• Tracking Progress and Escalating: Monitor project status, adjust priorities in real time, and surface risks to the COO early.
• Holding the Team Accountable: Set team performance metrics and ensure the team delivers.

• Serve as the voice of manufacturing in new product design: review design inputs and outputs against IMMY capabilities and equipment, and flag unmanufacturable designs before inputs are locked.
• Review Process Performance and Material Qualification protocols against manufacturability inputs and confirm validation reflects actual manufacturing conditions.
• For CMO products: confirm the design fits the CMO’s validated capabilities and has testable requirements verifiable by IMMY’s incoming QC.

• Define the criteria PD must meet before transfer, set the DHF handoff protocol with Technical Project Managers, and hold the transfer readiness gate regardless of schedule pressure.
• Own each product’s manufacturability and design controls compliance once accepted from PD, throughout its commercial life.
• Develop and oversee each product’s manufacturing transfer plan, including IQ/OQ/PQ for new equipment and processes, and support DHF compilation.
• Oversee manufacturing characterization of each transferred product (cycle and lead time, yield, batch size, Right First-Time rate, labor hours, changeover) and authoring of work instructions, batch records, and packaging and labeling specifications as formal design outputs.
• Hand off a complete supply chain package to Procurement and Order Fulfillment (shipping protocols, BOM, Approved Supplier List, component specs, shelf life, hazmat).
• Accept first production lots against transfer criteria and own monitoring of commercial lots post-transfer according to transfer plan.
• For CMO products: contribute to the Technical Agreement, define validation requirements, accept or reject the CMO’s process, witness critical validation runs, and accept first CMO lots before release.

• Maintain the DHF as a living record of the device as currently manufactured, authoring amendments when post-market changes touch design-controlled parameters.
• Own…