Design Transfer & Lifecycle Engineering Technical Manager

Description

JOB PURPOSE

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.

ROLES AND RESPONSIBILITIES

LMA (Lead, Manage, and Accountability)

Lead

• 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.

Manage

• Allocating Work and Building Capacity: Assign work by capacity and expertise, track workload across concurrent transfers and lifecycle events, and escalate 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.

Accountability

• 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.

Design for Manufacturability and Product Development Partnership

• 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.

Design Transfer Leadership

• 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.

Lifecycle Engineering and Technical Stewardship

• Maintain the DHF as a living record of the device as currently manufactured, authoring amendments when post-market changes touch design-controlled parameters.
• Own Device Master Record (DMR) integrity across the LFA, EIA and PCR portfolio: set documentation standards and approve amendments, including CMO manufacturing specifications that support regulatory submissions.
• Serve as the Tier 2 manufacturing floor escalation point: diagnose whether a problem is a process or design issue, and hand off a clear diagnosis or technical package into change control, CAPA, or complaint investigation.
• Lead root cause analysis for complaints where design may be implicated, separating design issues from manufacturing nonconformances and user error, and author resulting design controls documentation.
• Oversee raw material qualification when suppliers change.
• Act as the design controls interface for PE and Make improvement projects: decide whether a change triggers design controls and document approved changes in the DMR.
• Perform engineering assessments on post-market change requests; approve, reject, or escalate.

Contract Manufacturing Organization (CMO) Design Controls Interface

• Contribute design controls and change notification language to the CMO Quality and Technical Agreement and serve as IMMY’s technical recipient for CMO change notifications.
• Assess CMO-initiated changes before they proceed; communicate approved IMMY changes formally and verify implementation before accepting the next lot.
• Serve as IMMY’s primary technical representative in CMO audits.

THE PERSON

Qualifications include:

• Experience: 5+ years in design assurance, design transfer, manufacturing engineering, or process engineering, preferably in an FDA-regulated or ISO-certified IVD or medical device environment, combining assay/formulation science, manufacturing floor, and design controls or tech transfer expertise.
• Education: Bachelor’s degree in chemistry, biochemistry, biology, a relevant engineering discipline, or related field; advanced degree a plus.
• Technical Proficiency: Working knowledge of FDA 21 CFR Part 820 or ISO 13485/9001 design controls, process qualification, and root cause analysis.

Leadership & Strategic Skills

• Player-coach orientation: executes the most complex technical work while developing the team.
• Proven ability to hold a transfer readiness gate or comparable design controls authority under schedule pressure, including saying no.
• Strong cross-functional leadership across PD, Quality, RA, PE, Manufacturing, Supply Chain, and an external CMO; able to build a team from scratch.

Operational Experience

• Hands-on formulation or assay experience: immunoassay, molecular diagnostics, or both, preferably with IVDs or medical devices.
• Direct manufacturing floor credibility: understands process parameters and in-process controls and quickly earns operators’ trust.
• Preferred: Experience maintaining design records in a regulated environment (post-market amendments, supplier change qualifications) and managing a CMO relationship from the design controls side.

Communication & Decision-Making

• Comfortable as the named technical decision-maker on science-affecting changes and design controls.
• Excellent written and verbal communication; produces regulated documentation that withstands regulatory scrutiny.
• Makes high-stakes judgment calls under pressure and incomplete information, pushes back constructively, and leads with humility.

Other Requirements

• Willingness to travel occasionally, including to CMO and supplier sites (<10%).

Equal Opportunity Employment: IMMY is committed to the principle of equal employment opportunity for all employees and applicants for employment and prohibits discrimination and harassment of any kind without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, and local laws. IMMY will not tolerate discrimination or harassment based on any of these characteristics. This policy applies to all terms and conditions of employment, including, but not limited to, recruiting, hiring, promotion, termination, leaves of absence, compensation, and training.

Background Check Policy: All offers of employment at IMMY are contingent upon clear, acceptable results of a thorough background check. IMMY performs all background checks in compliance with EEOC and FCRA regulations and all other applicable federal, state, and local laws.