Project Manager - Combination Products Development

Summary:

• Title: Project Manager, Combination Products Development

• The Project Manager will be accountable to the Program Manager Director for delivering on the strategy, plans and budget defined for the project portfolio.

Responsibilities include:

• Leadership of a portfolio of drug delivery system product development projects
• Tactical and strategic management of external device partners including acting as a key interface, managing the project governance process and forward-looking evaluation of potential partners
• Device financial management including budgeting, forecasting and long-range planning of delivery development expenses
• Representing the R&D organization to cross functional leadership through effective and timely communication
• Ensuring effective use of meetings by clearly defining objectives, agendas, inviting the team members specifically needed and publishing minutes and actions

Top 3-5 skills, experience or education:

• Experience in design controls in pharma/med device industry
• Proficiency leading cross-functional teams and communicating to leadership
• Experiencing managing complex program strategies/deliverables/timelines/risks,
• Experience working with external partners, proficient in standard PM tools and best practices

Qualifications:

• Required: Bachelors Degree in Engineering or related technical field
• Certification: Project Management Professional (PMP) Certification preferred
• 8+ years of experience in the combination product or medical device industry with proven experience in developing medical devices or combination products; broad experience in design controls, human factors studies, design verification/validation and usability studies.
• Leadership of technical professionals; proven effective leader to cross-functional teams
• Skilled in the initiation, selection, coordination and management of projects and have the ability to solve unique problems.
• Requires an in-depth understanding of the pharmaceutical and device product development cycle.
• Design history file, project management and product development experience is essential.
• Conflict resolution skills including persuasive management techniques required. Effective communication and people management capability.

Pay Range:

• $75-80/Hr

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)

Job Requirement

• PMP
• Medical Device
• Pharmaceutical
• Biotech
• Project Management
• combination product
• design controls
• human factors studies
• design verification
• usability studies
• Design history file
• DHF
• product development
• drug delivery system
• portfolio
• R&D
• Project Manager
• MS Project
• SpreadSheets
• Gantt Chart
• Dashboard

PMP Medical Device Pharmaceutical Biotech Project Management combination product design controls human factors studies design verification usability studies Design history file DHF product development drug delivery system portfolio R&D Project Manager MS Project SpreadSheets Gantt Chart Dashboard