Project Manager - Combination Product

To discuss this job opportunity, contact Deepak Arya via LinkedIn or email your updated resume to deepak.arya@collabera.com.

About the Role

The Project Manager will lead complex cross-functional programs supporting medical device and combination product development, including activities required for regulatory submission and commercialization. The role involves managing multiple projects while coordinating teams across R&D, Engineering, Manufacturing, Quality, Regulatory, Commercial, and external suppliers. Strong project planning, scheduling, governance, risk management, and stakeholder leadership capabilities are required.

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.

Requirements

• 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.

Pay

$65 to $75 an hour.

Schedule

• Hybrid — Tuesday-Thursday onsite; Monday & Friday remote.
• 12-month contract (possibility of extension based on business needs and performance).

Benefits

• 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 off (vacation, sick, and safe time)
• Paid parental leave
• Paid holidays annually (as applicable)