Now Hiring - Manufacturing Project Manager, Medical Device New Product Development in Irvine, CA

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 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:
Manages large-scale projects and/or programs for New Product Development
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.
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.
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
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
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.
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 such EU MDR development and implementation of devices used in surgical structural heart valve replacement procedures.
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.
Establishes and maintains program stakeholder relationships, expectations, and communications, both internal and external to the organization.
Owns one or more PMO continuous improvement activities.

Required Qualifications:
Bachelor's Degree in a related field
A minimum of eight years of relevant experience in managing projects/programs OR a mixture of engineering/R&D experience (Or six years with a Masters)
A minimum of fours years leading projects/programs
Experience in a r egulated industry

Preferred Qualifications:
Project Management Professional Certification (PMP)
Scrum Master Certification
New Product Development
Knowledge of EU medical device directives/regulations (MDD/MDR)
Medical Device experience

Additional Expectations:
Strong leadership skills and ability to influence change
Experience in facilitating change, including collaboration with management and executive stakeholders
Ability to interact professionally with all organizational levels and proactively escalate issues to appropriate levels of management in the organization
Ability to manage competing priorities in a fast-paced environment
Strict attention to detail
Working knowledge regarding usage of MS Office Suite, MS Project, and related project management systems (e.g., JIRA).
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
Excellent problem-solving, organizational, analytical and critical thinking skills
Must be able to work in a team environment, including external representatives and participating and presenting at meetings
Ability to lead meetings

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).

About Edwards Lifesciences

Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the worlds leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 18,500 individuals worldwide.

For us, helping patients is not a slogan - its our lifes work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life.

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.

For United States Applicants Only:
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
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