Device Technical Lead - Lead design and development activities for combination products as part of cross functional team. Take leading role in driving device selection as well as testing/manufacturing sites. Work collaboratively with CMC and drug product team to develop and manage integrated project plan from feasibility to BLA/NDA submission. Oversee relationships and activities with vendors and CMOs for materials and services. Manage internal or CMO process development to align with project plan and regulatory requirements. Responsible for design control deliverables and technical components of regulatory submissions.

Drug Delivery and Device Development team member within cross function team for commercialization of on-body and auto-injector delivery systems for various Alexion drug programs and indications. Manage vendor relationships and incorporate vendor design deliverables into Alexion documentation for regulatory filings.Lead and execute design control and feasibility activities for device development programs including changes to device or container or expansion into new indications.

BD Medical - Pharmaceutical Systems, Self Administered Injection Systems (SAIS)Device development for combination drug delivery systems working closely with pharmaceutical partners in Business-to-Business platform. Customer facing technical lead for customization program ensuring timely completion of R&D deliverables to meet critical time to market needs of pharma partners.Own functional responsibility as R&D lead, ensuring compliance to industry standards and various regulatory requirements, to release injection molded products for sale in U.S. and overseas markets. Work closely with cross functional team including global manufacturing sites and outside vendors to deliver quality product.Plan and execute Design Control activities for end to end product life cycle from feasibility and creation of Input specifications to Design Verification to Design transfer. Manage multiple customization programs simultaneously in extremely fast paced environment

BD Medication and Procedural Solutions, Injection Systems, Product EngineeringLead cross-functional team on high volume, disposable Class II medical devices to support product changes, Quality and Regulatory compliance, continuous improvement initiatives, and drive product line extensions. Drive project scope and timeline assessment, development, and execution through analysis of inputs to ensure successful completion of deliverables. Liaise between stakeholders and project team through communication of project progress, scope change, or other business directives. Responsible for managing multiple projects at any given time.Own R&D functional responsibility as technical lead, ensuring compliance to industry standards and various regulatory requirements, to release injection molded products for sale in U.S. and overseas markets. Develop and implement Design Verification strategies, based on design inputs for qualification of design and material changes to products, utilizing functional performance data and statistical tools. Provide work direction to extended R&D team members and technicians to meet project objectives, as well as ensuring quality of work, including approving various Design Outputs (engineering drawings, product and buy specifications etc) and test plans, protocols, and reports.Provide technical input to global BD manufacturing plants in the Americas, Europe, and Asia, to ensure appropriate process capability and meet compliance requirements for products and manufacturing equipment. Approve process validation plans and oversee execution of Installation, Operational, and Performance Qualifications.Utilize knowledge of Design Control to support BD remediation projects through identifying and assessing requirements, and carrying out actions to ensure continued compliance.

Analyzed Legacy Synthes product lines by function and design, to create new product families for implementation in global risk remediation initiative in compliance to EN ISO 14971-2012.Communicated and coordinated with cross-functional team to drive translation of product technique and design documents into failure modes, determined occurrence rates through complaints analysis, and harm severity levels to end–user or patient across all Synthes platforms: Trauma, Spine, Cranio-Maxillofacial, Biomaterials, and Power Tools.Established control plans and mitigation for Design/Clinical Risk management, and rationale for risk justification.

BD Medical Surgical Systems, Hypodermics and Anesthesia Platform, Sustaining Engineering (SE)Worked as part of cross-functional team on Class II and Class III medical devices to implement changes, close deviations, launch product line extensions for new markets.Project Manager for SE Team• Led cross-functional, multinational team in scope and timeline assessment and development.• Managed multiple projects at any given time to ensure successful completion of deliverables.• Liaised between stakeholders and project teamR&D Lead• Developed and implemented strategies for qualification of design and material changes to products. Determined appropriate design and acceptability of proposed resin for syringes and needles to meet product requirements. Used Six-Sigma techniques to verify process capability.• Led product line extensions to Brazil for Ministry of Health tender and to Kenya. Ensured regulatory compliance for sterilization, product packaging, and graphics/labels. • Created new variable in-process test method for the detection of high plunger forces in epidural syringes for CAPA remediation project. Established force specification after consultation with medical experts.R&D Engineer• Authored and approved protocols and reports for design verification, engineering studies, and process validations.• Performed ISO compliance evaluation of BD safety devicesDesign History File management and remediation• Utilized understanding of design control to audit internal team DHF reviews, for completeness and correctness, prior to official reviews