Director, Regional Device & Drug Delivery Center of Excellence

• Lead translation of customer User Needs into container closure and device strategies aligned to dosing, patient population, and route of delivery
• Own Label & Packaging design activities, including DFM of packaging and linkage with the Design Lab for concept development and iteration
• Direct device assembly and test process design from concept samples through Design Verification samples
• Define and deploy scale-appropriate automation strategies for clinical and commercial programs
• Establish assembly in-process controls and inspection concepts to ensure consistent build quality
• Oversee metrology strategy supporting lot release and regulatory submission data packages
• Drive a Right First Time validation philosophy and remove variability sources before qualification
• Embed and maintain ISO 14971 risk management across the product lifecycle
• Provide technical leadership for regulatory strategy and support 510(k) and combination product submissions with Regulatory Affairs and QA
• Lead cross-functional device root-cause investigations using device knowledge, high-speed camera analysis, CT scans, and X-ray imaging
• Translate root-cause findings into control plans aligned with ISO 14971
• Represent the RTC in client-facing technical discussions, proposal development, and program governance
• Translate complex device engineering activity into clear risk, timeline, and investment narratives for pharma partners
• Liaise with stakeholders across the organization and external OEMs to achieve successful outcomes
• Carry out supervisory responsibilities including interviewing, hiring, training, work direction, performance appraisal, rewards, discipline, complaint handling, and problem resolution

• Bachelor's degree in Mechanical, Electronic, Biomedical, or Manufacturing Engineering (advanced degree preferred)
• 5+ years' experience in combination product / drug delivery device development, with at least 3 years in a senior leadership role
• Expertise in autoinjector, pen injector, or needle safety device design, assembly, and industrialization
• Working knowledge of ISO 11608, ISO 11040, ISO 14971, metrology equipment, ISTA/ASTM transport standards, and design controls (DHF/DMR)
• Experience supporting 510(k) submissions and combination product regulatory pathways (FDA, EU MDR/CTR as applicable)
• Track record of building or leading a technical center, lab, or center of excellence supporting external pharmaceutical clients
• Familiarity with root-cause investigation tools (CT scan, X-ray, high-speed imaging) and automation/tooling program management
• Strong client-facing communication skills
• Ability to operate at technical depth and executive summary level
• Ability to translate customer feedback into product solutions
• Self-motivated multitasker with high attention to detail
• Track record in developing and executing product launches
• Efficient with a focus on timelines and due dates
• Experience with device platform partnerships and managing external SME networks (preferred)
• Familiarity with DFM/DFA methodologies and statistical process control in a regulated manufacturing environment (preferred)
• Experience managing multi-program portfolios across clinical and commercial stage clients simultaneously (preferred)

Demonstrates expertise in combination product and drug delivery device development, with a strong focus on regulatory strategy, risk management, and cross-functional leadership. Proven ability to translate user needs into effective design and assembly strategies while ensuring compliance with industry standards.

• Combination Product Development
• Regulatory Submissions (510(k), EU MDR/CTR)
• ISO 14971 Risk Management
• Device Design (Autoinjector, Pen Injector)
• Root-Cause Investigation Tools (CT Scan, X-Ray)

• Device Assembly Design
• Automation Strategies
• Statistical Process Control
• Design Controls (DHF/DMR)
• Metrology Equipment

• Client-Facing Communication
• Multitasking
• Attention to Detail
• Problem Resolution

• ISO 11608
• ISO 11040
• DFM/DFA Methodologies
• Transport Standards (ISTA/ASTM)
• Regulated Manufacturing Environment

• High-Speed Imaging
• X-Ray Imaging
• CT Scans