Project Manager

at  Confluent Medical Technologies

Job Description:
Confluent Medical Technologies is dedicated to working collaboratively with our customers, taking their projects from rapid prototype into high volume production. Our unparalleled technical expertise, proven experience and partnership with our clients has allowed us to perfect the process necessary to deliver world-class medical devices through innovative material science, engineering, and manufacturing. Our primary capabilities include: Nitinol components, balloon expandable stents and balloon catheters, delivery systems, biomedical textiles, access kits, and guidewires. We take pride in our position as the leader in the medical technology space and are driven by a passion to create products that our clients have envisioned for their customers.
At Confluent, we are committed to our values of teamwork, innovation, accountability, integrity, leadership, and customer focus, and we invest in a team who represents these values. Every member of our team plays a critical role in delivering life-saving medical devices through innovative materials science, engineering, and manufacturing. We are the medical device industry’s most trusted partner, and we accomplish this with an organization focused on safety, efficiency, and customer satisfaction.
We are looking for a Project Manager to join our team in Costa Rica. If you enjoy working in a fast-paced environment and making an impact on our life-saving work, this may be a good fit for you! As a uniquely qualified candidate, you will:
SUMMARY: Project Manager I role requires a strong blend of technical, project management and business acumen to provide project-level leadership for our rapidly growing technology portfolio. The ideal candidate has previously worked as a design or process engineer and has strong project management and customer facing skills. This person will also have excellent interpersonal, organizational, and communication skills. The ability to fluidly shift focus between technical details and big-picture thinking is critical to this role.

ESSENTIAL DUTIES AND RESPONSABILITIES include the following. Other duties may be assigned.

• Confer with management, production, and marketing staff to discuss project specifications and procedures
• Significant experience scoping, planning, executing, and closing complex medical device projects including but not limited to process improvements, new developments, process transfers, cost improvement and complex engineering change orders.
• Knowledge of project management basics including schedule building, tracking, management, and communication.
• Budget management.
• Risk management.
• Ability to define and manage scope across the product development life cycle.
• Establishment, organization, facilitation, and effective follow-up for cross-functional team meetings.
• Strengths in relationship building through technical know-how; able to lead SME’s through influence & credibility.
• Ability to lead teams through a systematic Stage Gate project process.
• Experience organizing and presenting key project metrics, progress, and risks during Project Reviews.
• Ability to multi-task between projects as directed by Product Development and Engineering Manager. Capable of performing under the pressure of multiple competing deadlines while maintaining a cooperative and constructive working relationship with colleagues is essential.
• Outstanding verbal & written communication skills.
• Experience and savvy in dealing with external customers.
• Ability to forge strong, transparent customer relationships while also protecting Confluent’s interests.
• Skilled at customer negotiation and ensuring common understanding of requirements & expectations.
• Strong presentation capabilities including ability to develop and deliver formal communications.
• Ability to quickly & constructively respond to the unexpected, balancing tact, negotiation, and directness.
• Business Skills & Aptitudes
• Ability to develop insight into internal & external business models, performance metrics, & financial drivers.
• Strong ability to manage project budgets.
• Experience with financial tools including P&L, NPV, EBITDA, GM, and Cost Modeling.
• Medical Device Experience
• Direct experience with at least one of the following areas:
• Minimally invasive implantable devices including vascular stents, grafts, filters & accessories.
• Orthopedic devices & surgical instrumentation.
• Cardiac devices including structural heart solutions, CRM, electrophysiology, and heart pumps.
• Knowledge of FDA & ISO regulations, quality systems, design control and stage-gate reviews.
• Fluency with statistical concepts and techniques typically used in a medical device environment including sampling plans, TMV’s process capability, and reliability and confidence intervals.
• Technical Abilities
• Foundational skills in material science, chemical engineering, industrial engineering, or a scientific discipline.
• Previous hands-on experience with device design, analysis, testing, and/or process engineering.
• Ability to effectively engage technical Subject Matter Experts to influence outcomes & achieve project objectives.

EDUCATION and/or EXPERIENCE: Bachelor degree in a technical field (engineering or science). MS in Project Management is a plus. 6-7 years of end-to-end project management experience in a regulated environment.
PMP Certification and/or Professional Project Management Certificate.
COMMENTS: This position description is an outline of the major recurring responsibilities of the job. It is not intended to be all-inclusive of the work to be performed. The incumbent(s) will typically perform other related job objectives, special assignments and less significant responsibilities

• Confer with management, production, and marketing staff to discuss project specifications and procedures
• Significant experience scoping, planning, executing, and closing complex medical device projects including but not limited to process improvements, new developments, process transfers, cost improvement and complex engineering change orders.
• Knowledge of project management basics including schedule building, tracking, management, and communication.
• Budget management.
• Risk management.
• Ability to define and manage scope across the product development life cycle.
• Establishment, organization, facilitation, and effective follow-up for cross-functional team meetings.
• Strengths in relationship building through technical know-how; able to lead SME’s through influence & credibility.
• Ability to lead teams through a systematic Stage Gate project process.
• Experience organizing and presenting key project metrics, progress, and risks during Project Reviews.
• Ability to multi-task between projects as directed by Product Development and Engineering Manager. Capable of performing under the pressure of multiple competing deadlines while maintaining a cooperative and constructive working relationship with colleagues is essential.
• Outstanding verbal & written communication skills.
• Experience and savvy in dealing with external customers.
• Ability to forge strong, transparent customer relationships while also protecting Confluent’s interests.
• Skilled at customer negotiation and ensuring common understanding of requirements & expectations.
• Strong presentation capabilities including ability to develop and deliver formal communications.
• Ability to quickly & constructively respond to the unexpected, balancing tact, negotiation, and directness.
• Business Skills & Aptitudes
• Ability to develop insight into internal & external business models, performance metrics, & financial drivers.
• Strong ability to manage project budgets.
• Experience with financial tools including P&L, NPV, EBITDA, GM, and Cost Modeling.
• Medical Device Experience
• Direct experience with at least one of the following areas:
• Minimally invasive implantable devices including vascular stents, grafts, filters & accessories.
• Orthopedic devices & surgical instrumentation.
• Cardiac devices including structural heart solutions, CRM, electrophysiology, and heart pumps.
• Knowledge of FDA & ISO regulations, quality systems, design control and stage-gate reviews.
• Fluency with statistical concepts and techniques typically used in a medical device environment including sampling plans, TMV’s process capability, and reliability and confidence intervals.
• Technical Abilities
• Foundational skills in material science, chemical engineering, industrial engineering, or a scientific discipline.
• Previous hands-on experience with device design, analysis, testing, and/or process engineering.
• Ability to effectively engage technical Subject Matter Experts to influence outcomes & achieve project objectives