Project Manager II

Confluent Medical Technologies is growing! We're looking for a Project Manager II to join our Fremont, CA team!

Responsibilities:

• Foundational skills in mechanical engineering, material science, biomedical engineering, or a scientific discipline.
• Previous hands-on experience with device design, analysis, testing, and/or process engineering.
• Understanding of Validations (IQ/OQ/PQ Processes). Ability to coordinate and aid in formal Process Validations including protocol development, Engineering production runs and overall execution.
• Capable of performing under the pressure of multiple competing deadlines while maintaining a cooperative and constructive working relationship with colleagues is essential.
• Knowledge of with statistical concepts and techniques typically used in a medical device environment. 
• Demonstrated experience/knowledge of product development lifecycles.
• Work collaboratively with cross functional team to decompose project goals into clearly defined deliverables, activities, work tasks, and action items. 
• Co-ordinate and support manufacturing implementation and transfer to receiving facility.

Project Management:

• Ability to lead teams through a systematic Stage Gate product development process.
• Establishment, organization, facilitation, and effective follow-up for cross-functional team meetings.
• Ability to define and manage scope across the product development life cycle.
• Strengths in relationship building through technical know-how; able to lead SME’s through influence & credibility.

Customer-Facing Skills:

• Outstanding verbal & written communication skills.
• Experience and savvy in dealing with external customers.
• Skilled at customer negotiation and ensuring common understanding of requirements & expectations.
• Strong presentation capabilities including ability to develop and deliver formal communications.

 Medical Device Experience:

• Direct experience in medical device development required.
• Knowledge of FDA & ISO regulations, quality systems, design control and stage-gate reviews.
• Experience in minimally invasive implantable devices including vascular stents, grafts, filters & accessories desired.

Education & Experience:

• BS degree in a technical field (engineering or science). MS preferred.
• Minimum 2+ years of engineering experience plus minimum 2+ experience in project management.
• Experience managing customer relationships
• PMP Certification or Professional Project Management Certificate a plus.

Confluent Medical Technologies offers very competitive compensation and benefits and is proud to have a distinguished reputation throughout the medical device industry around the world! We welcome eager and ambitious team players to apply. There’s no better time to join Confluent!
Qualified candidates will be contacted. No phone, fax or email inquiries from potential applicants, external recruiters or other interested parties, please.
We regret that we are unable to sponsor employment visas or consider individuals on a time-limited visa status for this position.