Director, Design Transfer

Position Summary

The Director of Design Transfer is a pivotal leadership role responsible for overseeing the seamless transition of medical device designs from the development phase into full-scale manufacturing. This role ensures that all design specifications, quality standards, and regulatory requirements are meticulously integrated into manufacturing processes. The Director will collaborate cross-functionally with R&D, Quality Assurance, Regulatory Affairs, Manufacturing, and Supply Chain teams to facilitate efficient, cost-effective, and compliant product launches.

Principal Responsibilities

1. Strategic Leadership and Management
•    Team Leadership & Culture
o    Provide direction and mentorship to the Design Transfer team, conduct performance evaluations, and foster a collaborative, high-performance environment, placing accountability at the core. Implement and live a can-do mindset in everything you do. 
•    Strategic Planning & Budget Management
o    Develop and implement robust design transfer strategies aligned with organizational goals. Create and manage capital and operational budgets to ensure cost-effective operations.
•    Resource Optimization & Accountability
o    Allocate resources effectively, ensuring project deadlines and objectives are met while maintaining accountability for overall results

2. Cross-Functional Collaboration and Project Execution
•    Interdepartmental Coordination
o    Partner with Design & Development, Design Assurance, Regulatory Affairs, and Global Supply Chain to align design requirements to production and process controls, ensure manufacturability, and maintain compliance with standards (e.g., FDA, ISO 13485).
o    Own manufacturing deliverables related to design transfer activities that meet our design control and C2C processes. These include but are not limited to the manufacturing plan, control plans, make vs. buy, COGs estimates, design transfer checklist and design transfer readiness. 
•    Supplier & Stakeholder Engagement
o    Manage suppliers related to new products to ensure design intent is communicated appropriately, design includes proper supplier controls and manage readiness for production.
•    Project Management & Communication
o    Work with PMO to lead cross-functional project teams, track progress, and provide regular project updates to senior management. Maintain clear communication channels internally and externally.

3. Technical Expertise
•    Process Development & Validation
o    Develop, validate, and optimize manufacturing processes, equipment, and tooling to align with design intent and regulatory standards. Own equipment and software documentation. 
o    Implement production control plans that can include SPC
•    Regulatory Compliance & Risk Management
o    Prepare and support regulatory submissions, audits, and risk assessments (FMEA) to ensure full compliance. Anticipate and mitigate manufacturing and regulatory challenges.
o    Utilize and own process readiness assessment (PRE) tool as part of the design transfer process. 
•    Continuous Improvement & Post-Launch Support
o    Use KPIs to evaluate performance, drive cost-effective quality improvements, and oversee post-launch process enhancements. Incorporate feedback into product and process refinements.
o    Own stability metrics and actions pre- and post-launch. 
 

Education / Experience Requirements

•    Bachelors Degree required in an applicable field, graduate degree preferred.
•    10+ years of relevant experience required, preferable in a manufacturing environment.
•    Previous managerial experience leading cross functional and multi-site teams. 
 

Specialized Skills / Other Requirements

•    Ability to independently manage and lead larger projects from inception to completion. Ability to engaged effectively in a matrix environment, with ownership and accountability to project timelines.
•    Strong working knowldedge of processes and equipment common to medical device manufacturing; examples include additive manufacturing, machining, extrusion, injection molding, coating, adhesive and thermal bonding, etc.
•    Extensive knowledge of risk management principles and Implementation and/or knowledge of SPC.
•    Experience with and working knowledge of ISO13485, FDA and GMP requirements. 
 

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Working Conditions / Physical Demands

TRAVEL REQUIRED: 20%

WORKING ENVIRONMENT:
☒ Office/Professional        ☐ Plant/Manufacturing    ☐ Remote/Field     ☐ Laboratory