Project Manager (Medical Device)

This Manager, Project Management role is an exciting opportunity to be a part of the Surgical Structural Heart Valve organization. This project management position is focused on Edwards Lifesciences’ products involving cross-functional teams working on EU MDR Surgical Heart Valve product submissions and implementations. You will have a key role in owning the Product Development Process tools and templates, driving continuous process improvement and refinements across teams and company.
Key Responsibilities:

• Responsible for all areas of project management, focusing heavily on schedule management, performance metrics, resource management, risk management, communications management, and process development and improvement.
• Executes program plans (quality, risk, communication, staffing, etc.) and communicates program status and data in order to maintain accurate and current program information for the use of stakeholders
• Develops a high-level milestone plan for the program and manages program change in accordance with the change management plan to control scope, quality, schedule and cost
• Collaborates with all project functions including R&D, Quality, Manufacturing, Marketing, Regulatory, and Supply Chain.
• Responsible for leading the cross-functional project team through the Edwards design control process.
• May serve as a representative of the Project Management Office (PMO) in working directly with PMOs in other Edwards business units and enterprise-wide initiatives.
• Serves as a project and program management subject matter expert, including guiding and mentoring project managers; sourcing and directing contract resources tied to projects within the program; and develops expertise in a business process, professional discipline, market or product.
• Owns one or more PMO continuous improvement activities.
• Establishes and maintains program stakeholder relationships, expectations, and communications, both internal and external to the organization.
• Responsible for coordinating with, presenting to, and establishing rapport with all levels of project stakeholders including mid-level and executive functional and business unit leadership, global supply chain, shared services, and corporate counterparts.
• Manages large-scale projects and/or programs for the EU MDR development and implementation of devices used in surgical structural heart valve replacement procedures.

Required Qualifications:

• A minimum of eight years of experience managing projects and/or programs and engineering/R&D (Or six years with a Masters)
• Experience in a regulated industry
• Bachelor's Degree in a related field

Preferred Qualifications:

• Knowledge of EU medical device directives/regulations (MDD/MDR)
• Medical Device experience
• Scrum Master Certification
• Project Management Professional Certification (PMP)

Additional Expectations:

• Must be able to work in a team environment, including external representatives and participating and presenting at meetings
• Strict attention to detail
• Experience in facilitating change, including collaboration with management and executive stakeholders
• Strong leadership skills and ability to influence change
• Ability to lead meetings
• Excellent documentation and communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives
• Expert understanding and knowledge of principles, theories, and concepts relevant to managing multiple projects within an overall program
• Ability to interact professionally with all organizational levels and proactively escalate issues to appropriate levels of management in the organization
• Excellent problem-solving, organizational, analytical and critical thinking skills
• Ability to manage competing priorities in a fast-paced environment
• Working knowledge regarding usage of MS Office Suite, MS Project, and related project management systems (e.g., JIRA).

Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.
For California, the base pay range for this position is $106,000 to $151,000 (highly experienced).
The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience).
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
COVID Vaccination Requirement
Edwards is committed to complying with the requirements and guidance from our government authorities and to protecting our vulnerable patients and the healthcare providers who are treating them around the world. As such, all Healthcare Interacting positions require COVID-19 vaccination, which includes anyone who directly interfaces with patients and those who interact with healthcare providers as part of their role. If hired, as a condition of employment, you will be required to submit proof that you have been fully vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in countries where it is prohibited by law to impose vaccination. In countries where vaccines are less available, or other requirements exist, we may institute alternate measures that optimize patient safety and healthcare provider safety, which may include regular COVID testing or specific masking requirements.