Project Manager - Combination Product

Job Mode: Hybrid — Tuesday–Thursday onsite; Monday & Friday remote Duration: 12 Months Contract (Possibility of Extension based on business needs and performance) Job Summary: The Project Manager will lead complex cross functional programs supporting medical device and combination product development and activities required for regulatory submission and commercialization. The role will manage multiple projects while coordinating teams across R&D, Engineering, Manufacturing, Quality, Regulatory, Commercial, and external suppliers. The position requires strong project planning, scheduling, governance, risk management, and stakeholder leadership capabilities. The successful candidate will independently manage project timelines, establish milestones, resolve obstacles, and maintain accountability across diverse teams. Strong MS Project experience and direct knowledge of medical device design controls are essential. Key Responsibilities: Lead cross functional project teams supporting medical device and combination product development. Manage approximately 2 to 3 projects based on project complexity and scope. Develop, maintain, and baseline detailed project schedules using MS Project. Establish project milestones, dependencies, timelines, resources, priorities, and deliverables. Coordinate project planning activities with R&D, Engineering, Manufacturing, Quality, Regulatory, Commercial, and external stakeholders. Coordinate design reviews and activities supporting product development and regulatory submission. Maintain project logs covering action items, assumptions, decisions, risks, and issues. Track project progress and hold team members accountable for agreed timelines and deliverables. Identify project obstacles and coordinate resolution with appropriate stakeholders. Facilitate cross functional meetings and maintain effective communication across project teams. Prepare meeting minutes and follow up on action items. Develop and maintain project dashboards and management reporting. Prepare and present project updates and materials for governance and leadership meetings. Manage project budgets, schedules, resources, risks, and overall project execution. Coordinate activities with third party suppliers, vendors, contractors, and external organizations. Support technical transfers, product maintenance, new product introduction activities, and global product development programs as applicable. Drive process improvement initiatives that improve efficiency, quality, compliance, and cost effectiveness. Facilitate conflict resolution and help teams reach timely decisions. Keep leadership informed of project status, risks, decisions, issues, and recommended actions. Coordinate effectively with global teams and stakeholders across different time zones. Support program management process development and continuous improvement activities. Comply with applicable EHS policies, procedures, training, and workplace safety requirements. Required Qualifications: Bachelor's degree in Engineering, Science, or a related discipline. Approximately 10 or more years of diversified business or project management experience. Direct experience with medical devices and or combination products. Hands on experience with medical device design controls and design review processes. Strong hands on experience with MS Project for project planning, scheduling, baselining, milestone tracking, dependencies, resource management, and reporting. Proven ability to independently lead large and complex cross functional teams. Experience coordinating stakeholders across R&D, Engineering, Manufacturing, Quality, Regulatory, Commercial, and external suppliers. Strong project planning, scheduling, risk management, issue tracking, and governance experience. Excellent verbal, written, and interpersonal communication skills. Strong stakeholder management, conflict resolution, consensus building, and influencing skills. Ability to make timely decisions and move projects forward with incomplete information. Strong proficiency with MS Office, including Excel and PowerPoint. Preferred Qualifications: Pharmaceutical industry experience. Experience with new product introduction programs. Experience with technical transfers, product maintenance, or global product programs. Experience supporting product development through regulatory submission. Experience with Smartsheet or Monday.com. PMI certification. Lean Six Sigma Green Belt or Black Belt certification. Experience with supply chain, validation, capital and expense management, or plant level operations support. Experience working with international or global teams. Advanced business degree. Benefits: The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan, life insurance, long-term disability insurance, short-term disability insurance, paid parking/public transportation, (paid time , paid sick and safe time , hours of paid vacation time, weeks of paid parental leave, paid holidays annually - As Applicable) #J-18808-Ljbffr Collabera Inc.