Senior Project Manager, Product Transfer

Position Summary 

A new and exciting Senior Project Manager role supporting high visibility product transfers focused in the neurovascular space, with potential for cross divisional projects. You will work with suppliers around the globe to qualify technically challenging components coming into our Neurovascular manufacturing plants. This role is perfect for a Project Manager that thrives in a dynamic environment and enjoys working on new types of technologies, and working across global teams, while continuing to build their project management skillset. 

What you will do:

• Support initial project evaluations- including supporting business case evaluations, supplier and project vetting. 
• Partner with cross-functional team members to develop project strategies and drive alignment with business objectives. 
• Influence and motivate your project teams to develop innovative and best-in-class products for our customers.
• Adapt to changing business dynamics while maintaining strong team leadership and focus on organizational strategy.
• Support a wide range of projects in various development phases ranging from early concept feasibility to commercialization.
• Build bridges and negotiate solutions, influencing and communicating within and outside your team, driving decisions across all levels of the organization.
• Contribute to the standardization of the project management best practices and seeking opportunities to harmonize processes and systems across programs,

What you will need:

• Bachelor’s Degree related to Engineering or other related field of study
• 4+ years of work experience
• 2+ years proven project management experience
• Experience with product transfers in a regulated industry
• Work experience in medical device and/or biotech field
• Experience with design remediation and engineering development, including IQ/OQ/PQ, and design verification & validation
• PMP certification
• Knowledge of 21 CFR 820.30 - Design Controls and ISO 13485 section 7.3 - Design and Development
• A track record of contributing to successful medical device product introduction including at least one significant project from proof-of-concept through pilot production
• Ability to create & manage budgets, timelines, and risks within a contracted commitment
• The ability to analyze complex situations, distill issues, develop insights, challenge the status quo, and synthesize recommendations
• Strong negotiation to gain consensus and across the organization vertically and horizontally

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