Device Director Combination Products

Our client is seeking a Device Director for Combination Products. This role will be responsible for leading the development and commercialization of combination products and delivery devices supporting the client's pipeline while providing sustaining support for current and future commercialized products. Provide engineering expertise as a leadership team member with current product improvements and future product line expansions. Develop operating plans and organize top talent to support those plans. Responsibilities Direct a staff composed of individuals at various scientific and engineering levels, organize team to provide proper task execution while maintaining a team environment. Provide technical leadership in new product portfolios and technology development. Lead the specification, design, documentation and verification/validation through product transfer of the device aspects of new products. Develop and communicate departmental plans, including budgets, timelines and goals. Coordinate approach for Design Control documentation across projects, leveraging platform strategy. Provide leadership and support to define standard work, strategy development and execution of Design Controls. Seek ways to improve governance processes and structures to enhance efficiency and cross-platform learnings. Research, plan, organize and lead projects through the design control process. Plan and manage project budgets; monitor actual project expenses to budget and department resources; proactively manage budget and variances. Lead phased implementations of design and process updates to achieve project schedules and cost targets. Establish collaborative working relationships with vendors, provide effective oversight of suppliers, manage technical aspects of the device suppliers, combination product fill and finish CMOs, contract device assembling, packaging, human factor, and/or usability development organizations. Follow appropriate internal quality initiatives, including applicable SOPs, Work Instructions, and external quality initiatives, including FDA regulations and guidance documents. Build effective relationships with cross-functional management and leadership team members. Perform other duties as assigned. Qualifications Bachelor of Science in Biomedical Engineering, Mechanical Engineering, Chemical Engineering, Electrical Engineering or a similar field. Master's Degree preferred. 12+ years of experience in product development or engineering. Significant experience with medical device or combination product commercialization, operations support, and materials/components. Proven track record of successful leadership developing and launching new products. Demonstrated success in providing strong technical leadership and strong partnering with Marketing, Commercial, Product Management, Operations, and QA/RA. Proven leader in devising and implementing streamlined processes to improve efficiency, timeliness, and productivity. Ability to align and manage multiple projects simultaneously and achieve scheduled milestones; demonstrate risk project management, including contingency planning. Ability to guide technical resources in the translation of marketing requirements into design specifications. Ability to provide technical leadership in material and component selection to mitigate technical and supply chain risks. Familiar with regulatory requirements for combination products worldwide, with experience in FDA regulations and EU-MDR and Notified Bodies. Experience authoring documentation associated with Design Controls and Notified Body Opinions requests (GSPR). Attention to detail and an ability to absorb and assimilate information rapidly. Strong team-working and communication skills. Strong competency using office software including MS Word, Excel, MS Project, and PowerPoint. Strong collaborative skills, creative problem-solving, keen attention to details and outstanding organizational abilities. Excellent written and oral communication skills. Location Wilmington, DE Employment Type Direct Placement About Ventura Solutions Ventura Solutions is a reputable end-to-end medical device and combination product consulting, staffing, and training firm. With our deep industry expertise spanning medical devices and combination products, coupled with an outstanding talent pool, we stand out as the preferred option for a diverse array of projects. On the consulting side, we integrate seamlessly into your team and manage small to complex Statement of Work (SOW) projects. On the staffing side, we help source, screen, and onboard reputable employees to fill temporary, temp to permanent, and permanent job openings. We accelerate product development, keep products compliant, and help build great organizations. For more information, visit us at . Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities#J-18808-Ljbffr

Created: 2025-03-10