Director Engineering, New Product Development

Edwards Lifesciences; Irvine (CA); On-site; USD 159,000 - 226,000; Full time

Benefits offered by this job

Competitive salaries

Performance-based incentives

Wide variety of benefits programs

Job summary

Edwards Lifesciences is seeking a Manufacturing Engineer Manager to lead the development, qualification, and transfer of processes in Irvine, California. In this role, you’ll manage a team and ensure that production meets operational needs for successful outcomes.

Ideal candidates will possess a Bachelor’s degree in engineering, extensive experience in the medical device industry, and strong leadership skills. You'll play a vital role in delivering innovative solutions to meet critical patient needs.

Qualifications

• 5+ years of manufacturing operations experience in the medical device industry.
• 12 years of overall engineering experience with 5 years in leadership.
• Knowledge of design controls for Class II & III medical devices.

Responsibilities

• Manage a team of manufacturing engineers to develop and qualify manufacturing processes.
• Liaise between various departments to ensure seamless product delivery.
• Plan and manage project activities with accountability for deliverables.

Skills

Manufacturing operations

Project management

Cross-functional collaboration

Technical leadership

Six Sigma

LEAN methodologies

Emotional intelligence

Education

Bachelor's Degree in engineering or scientific discipline

Advanced engineering degree

Job description

Imagine how your ideas and expertise can change a patient’s life. Our Global Operations & Quality team plays a central part in ensuring our products are delivered to patients with cardiovascular disease. You’ll partner cross-functionally with manufacturing operations and sales teams, delivering thoughtful solutions to complex challenges all while developing your knowledge of the medical device industry. Whether your work includes strategic inventory planning, labeling, warehouse management, material handling, or any of our other supply chain opportunities, you will be making a meaningful contribution to our team and to patients all over the world.

Dedicated to innovation, our Surgical business unit is focused on identifying and solving critical, unmet needs in cardiac surgery. In understanding the challenges of open-heart surgery, we partner with surgical teams to deliver modern technologies intended to enhance patients’ quality of life and expand their potential treatment opportunities. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.

How you will make an impact

• 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.
• Advance 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.
• Act as a liaison between R&D, supplier development, Global Supply Chain (GSC), quality, and sustaining operations to ensure readiness to seamlessly plan, source, make and deliver the product to customers around the world.
• Partner with New Product Introduction Managers, Pilot and Sustaining Operations, and Edwards manufacturing global locations 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.
• 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.
• Manage/oversee the work direct reports within own function and/or cross functional project teams. Support the development of PMOs and individual development plans (IDPs) for the team. Develop a robust talent development plan in alignment with functional growth strategies of the individual and the department.
• 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).

What you’ll need

• Bachelor's Degree in engineering or scientific discipline.
• Manufacturing operations experience with five of those years in the product development process and introduction of new products into supply chain in the medical device industry.
• Experience in preparing for and presenting project status to executive leadership, including the development, and managing of dashboards.
• Willingness to travel up to 25%, both domestically and internationally, as required to support business and manufacturing needs.
• On‑site presence required to effectively lead teams, collaborate cross‑functionally, and support manufacturing operations.

What else we look for

• Advanced engineering degree and/or Six Sigma Black Belt certification.
• Experience in the medical device industry.
• 12 years of experience with 5 years of people leadership experience.
• 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 set clear expectations and orchestrate all Operations activities related to planning, sourcing, manufacturing, distribution, and associated functions.
• 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.
• 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 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.

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 $159,000 to $226,000 (highly experienced).

The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website.

Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.

COVID Vaccination Requirement

Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been 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 locations where it is prohibited by law to impose vaccination.