Job Description:

Innovation starts from the heart. Edwards Lifesciences is the leading global structural heart innovation company, driven by a passion to improve patient lives. With millions of patients served in over 100 countries, each team makes a meaningful contribution by improving patient outcomes and discovering lasting solutions for unmet patient needs. Our Sr. Director, Injection Molding – Worldwide Engineering position is a unique career opportunity that could be your next step towards an exciting future.

The Sr. Director, Injection Molding – Worldwide Engineering will develop strategy and lead teams to execute supplier category plans that ensure technical sustainability of quality component supply, at scale, across Edwards Businesses and Networks including setting Engineering standards and best practices for category areas, developing and/or selecting appropriate technologies and processes, and being responsible for supplier technical evaluation, partner selection, component and technology validation, transfer, and integration, as well as identifying supply risks, mitigations and business impact in concert with cross-functional teams from global Operations and New Product Development sites.

How you will make an impact:
• Set Engineering standards and best practices for category technology. Oversee the analysis and the resolution of complex Manufacturing and Compliance issues (e.g., CAPA, non-conformances, audit observations).
• Plan and direct strategic activities including prioritizing and selecting appropriate project portfolios with overall responsibility for meeting business objectives. Lead in identifying risk, developing complex mitigation strategies, best practices, alternative solutions, resolving issues, etc. in collaboration with cross functional and/or matrix teams. Ensure teams select, scale-up, and implement robust category processes to budget and schedule while maintaining compliance to comprehensive medical device standards. Ensure the appropriate implementation of design for manufacturing, design for cost, mistake proofing, and quality controls to minimize patient and regulatory compliance risks.
• Lead, develop, and attract experienced professionals organized across cross-functional teams focused on advancing Supplier category technologies that can manage both current and future business needs. Provide leadership in the global Technical Category strategy and associated supplier processes and management. Develop a robust and credo-based talent development and succession planning in alignment with functional growth strategies.
• Prepare business cases, supporting data, and presentation materials to facilitate strategic decision making and approval of new category technology portfolio strategies with Upper Management. Anticipate financial needs, quantifies budget to support project planning, and manages budget per forecast and schedules.
• Establish and apply a global scorecard and performance management process to ensure robust execution of category strategy, projects, and supply chain risk mitigation. Establish program level plans, global scorecards and performance management processes to ensure deliverables are completed in a timely and effective manner.
• Perform other duties and responsibilities as assigned.

What you’ll need (required):
• Bachelor's Degree in In Engineering and prior experience in developing components and processes used in the medical device industry, as well as significant experience in managing associated technical engineering functions.

• Extensive experience in hands on implementation and support of medical device technologies within a highly regulated cleanroom manufacturing environment

• Travel Requirements: 20%

What else we look for (preferred):

• Master's Degree in Engineering, Engineering Management, Technology plus 14 years of applicable experience OR

• PhD in Engineering, Engineering Management, Technology and/or Business Administration plus 11 years of applicable experience

• Experience working in a regulated industry
• Proven track record of successfully leading, developing, and mentoring highly educated, skilled engineering teams in a global environment.
• Proven ability to evaluate manufacturing processes and automation technologies, and develop a strategy for application of these systems that adds high value to the business.
• Demonstrated successful experience in a regulated industry within a manufacturing environment required
• Demonstrated, technically sound, engineering leadership background and proven successes in designing and implementing component and processes used in the Biomedical device industry.
• Proven success in influencing management strategic decisions to invest in both new and proven technologies and processes.
• Extensive experience in utilizing Six Sigma tools to develop new processes and improve existing processes, leading to manufacturing value creation.
• Extensive experience in strategic planning and project management.
• Excellent documentation and communication skills, interpersonal relationship skills including negotiating and relationship management skills, with ability to drive achievement of objectives.
• Expert understanding of engineering procedures while looking beyond existing methodologies and own discipline to define and resolve complex problems
• Expert knowledge and understanding of compliance Regulations that apply to Quality, Regulatory Compliance (21 CFR Part 11), Environmental Health and Safety, as well as have knowledge of standards related to equipment design and implementation into global medical device manufacturing plants.
• Technical and managerial leadership enabling process development in global manufacturing sites. Must be able to demonstrate evidence of engaging internal and external engineering resources toward harmonized goals and objectives
• Ability to serve as core partner to senior leaders in Business Units, Functional Groups, Regions and IT
• Strict attention to detail
• Ability to interact professionally with all organizational levels and proactively escalate issues to appropriate levels of management in the organization
• Ability to work and excel within a fast paced, dynamic, and constantly changing work environment
• Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control
 

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 (CA), the base pay range for this position is $187,000 to $265,000 (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.