🚀 Senior Director Engineering, Injection Molding

Overview

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 contributes to improving patient outcomes and discovering lasting solutions for unmet patient needs. The Sr. Director, Injection Molding – Worldwide Engineering position is a unique career opportunity within Edwards.

Responsibilities

• Set Engineering standards and best practices for category technology. Oversee the analysis and resolution of complex Manufacturing and Compliance issues (e.g., CAPA, non-conformances, audit observations).
• Plan and direct strategic activities including prioritizing and selecting project portfolios with overall responsibility for meeting business objectives. Identify risks, develop complex mitigation strategies, best practices, and alternative solutions 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 medical device standards. Implement design for manufacturing, design for cost, mistake-proofing, and quality controls to minimize patient and regulatory compliance risks.
• Lead, develop, and attract experienced professionals across cross-functional teams focused on advancing supplier category technologies to meet current and future business needs. Provide leadership in global Technical Category strategy and supplier processes. Develop talent development and succession planning aligned with growth strategies.
• Prepare business cases, data, and presentation materials to facilitate strategic decision-making and approval of new category technology portfolios. Anticipate financial needs, quantify budgets to support planning, and manage budgets 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. Create program-level plans and ensure deliverables are completed timely and effectively.
• Perform other duties and responsibilities as assigned.

What you’ll need (required)

• Bachelor’s Degree in Engineering and related experience in developing components and processes used in the medical device industry, with significant experience in managing associated technical engineering functions.
• Extensive hands-on experience implementing and supporting medical device technologies in 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 leading, developing, and mentoring engineering teams in a global environment.
• Ability to evaluate manufacturing processes and automation technologies and develop strategies for applying these systems to add value.
• Demonstrated experience in regulated manufacturing environments and biomedical device industry.
• Experience influencing management decisions to invest in new and proven technologies and processes.
• Extensive experience using Six Sigma tools to develop new processes and improve existing ones.
• Strong project management, planning, and communication skills.
• Understanding of quality, regulatory compliance (21 CFR Part 11), environmental health and safety, and equipment design standards for global medical device manufacturing.
• Ability to partner with senior leaders across units, regions, and IT.
• Attention to detail and ability to work in a fast-paced, dynamic environment.

Compensation and benefits

Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs. For California, the base pay range for this position is $187,000 to $265,000 (highly experienced). The pay for the successful candidate will depend on factors such as qualifications, education, and prior experience. Applications will be accepted while this position is posted on our Careers website.