Project Manager, Product Transfer

Who we want:

• Purpose-driven. A person who thrives when they have a mission that matters:
  “Together with our customers, we are driven to make healthcare better.”
• Leader.  A person who can direct, guide and influence the behavior and work of project teams towards accomplishing the program objectives.
• Collaborator. A relationship-savvy person who intentionally makes and strengthen connections with both internal partners and external contacts.
• Achiever.  A change agent who strives to accomplish tasks and are constantly driven to do more.
• Influencer: Partner with multiple functions (R&D, Pre-Clinical, Marketing, Quality Assurance, Operations, Supply Planning, Packaging) to drive product development fulfills our customer needs.

What you will do:

A new and exciting Project Manager role supporting product transfers in the neurovascular space. We expect you to grow your talents while learning and applying project and program management principles, stroke treatment techniques, and organizational best practices to ensure we deliver the best products to our customers.

We are looking for a Project Manager in our PMO who can:

• Partner with cross-functional leaders to develop comprehensive product development and lifecycle plans 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

Preferred Qualifications:

• 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 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