Job description

The Senior Manager of New Product Development is responsible to provide technical leadership and manage a team of manufacturing engineers to lead the development, qualification, and transfer of manufacturing processes to successfully commercialize new products in the Surgical Business Unit. This individual will advance the objectives of the Global Supply Chain (GSC) by supporting supply chain development and associated engineering activities from early product development through product launch while ensuring that manufacturing processes are developed that fully meet the operational needs for commercial success. The Senior Manager will act as a liaison between R&D, supplier development, quality, and sustaining operations to ensure readiness to seamlessly plan, source, make and deliver the product to customers around the world.

Essential job functions:
Manage/oversee the work of an assigned team of direct reports within own function and/or cross functional project teams. Ensure clarity of roles and responsibilities for each member of the team. Support the development of PMOs and individual development plans (IDPs) for the team. Provide coaching and feedback, including responsibility for employee actions by partnering with HR on all aspects of employee relations. Develop a robust talent development plan in alignment with functional growth strategies of the individual and the department.
Provide technical leadership for the Surgical business unit’s manufacturing engineering (ME) team for successful process development, design for manufacturability, design and process excellence methodologies including Six Sigma, LEAN, cGMP, EH&S guidelines, supplier development and process validation.
Work in close collaboration with NPI Managers, Pilot and Sustaining Operations, and Edwards manufacturing locations for the assigned program to ensure successful outcomes towards the development, scaleup and transfer of manufacturing operations including the development of harmonized validations strategies and attainment of stability metrics. Drive line and capacity expansion plans in manufacturing locations in collaboration with demand planning and commercial groups for uninterrupted product supply.
Identify risks across manufacturing operations including those associated with or arising from technology, materials, skills/competencies, design requirements etc. and develop mitigation strategies, define alternative solutions, resolve issues, and follow-up on action items in collaboration with cross functional groups and key stakeholders to deliver successful outcomes for the business.
Lead the development and implementation of tools/methodologies for effective problem-solving, failure analysis, root cause investigation and best practices for agile deployment of responses and robust solutions that deliver superior results that also elevate learning, critical thinking, and impact across the business. Seek advice and consult with centers of excellence (COEs) and subject matter experts to solve complex problems and get buy-in on new or unfamiliar challenges.
Ensure development and implementation of robust characterization and validation activities in collaboration with partners from R&D and quality, including deployment of critical control points (CCPs) in manufacturing. Prioritize the timely development of critical to quality (CTQ) design elements and cascading CTQs to design inputs / outputs and establishing process controls / limits.
Oversee the development of manufacturing tools, fixtures and equipment that provide the highest levels of quality and mistake proofing while meeting or exceeding requirements for reliability and robustness that meet Edwards standards for tools and fixtures including EH&S and ergonomic standards.
Plan and manage project activities (e.g., VIP/value engineering, COGS reduction activities, process improvement, etc.) with accountability for successful completion of all deliverables to the business. Where appropriate develop project plans, schedule, scope, and objectives while using engineering methods (e.g., SIX Sigma and LEAN methods).
Perform other duties and responsibilities as assigned.

Required Qualifications:
Bachelor's Degree in engineering or scientific discipline.
Minimum of 10 years of manufacturing operations experience with five of those years in the development and/or introduction of new products into supply chain a regulated industry.
Minimum of five years of leading cross functional teams and leading cross functional teams direct line reporting authority.
Strong collaborator and communicator with a high degree of emotional intelligence and the ability to understand business partner needs and manage satisfaction relative to deliverables.
Experience in preparing for and presenting project status to executive leadership, including the development, and managing of dashboards.
Ability to set clear expectations and orchestrate all Operations activities related to planning, sourcing, manufacturing, distribution, and associated functions.
Leadership and communication skills with extensive experience interacting and engaging stakeholders at multiple levels in the organization with track record of brand recognition and having established trust.
Experience in organizational change management possessing skills and ability to influence stakeholders, manage and socialize expectations, understand trade-offs and their impact, and mobilize cross functional teams to make effective business and patient focused decisions.
Excellent documentation and communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives.
Expert understanding of engineering procedures while addressing issues with impact beyond own team based on knowledge of related disciplines, and financial acumen as it relates to engineering.

Preferred Qualifications:
Advanced engineering degree.
Six sigma Black Belt certification.
Experience in the medical device industry.
Knowledge of design controls for Class II & III medical devices, including familiarity with one or more of the following: implantable NiTi, CoCr & tissue, mechanical devices, catheter-based delivery system.
Ability to influence cross-functional partners, business units, and/or sites and interact professionally with all organizational levels and proactively escalate issues to appropriate levels of management in the organization.

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 $123,000 to $174,000(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 world’s 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 13,000 individuals worldwide.

For us, helping patients is not a slogan - it’s our life’s 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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