Director - Device Product Stewardship

Merck KGaA Darmstadt Germany - Rahway, NJ

Full-time - Senior

Rahway, NJ

Chemical Manufacturing

About the position

The Director of Device Product Stewardship is responsible for leading technical support and product stewardship for key products in Merck's medical device and combination products portfolio. This role focuses on developing and executing lifecycle management plans, risk management strategies, and continuous improvement initiatives to ensure product safety, effectiveness, and compliance. The Director will oversee a team of technical experts and collaborate with various stakeholders to uphold quality standards and enhance product performance.

Responsibilities

• Provide strategic leadership and direction for technical support and product stewardship across assigned products.
• Develop, maintain, and refine technical product lifecycle management plans.
• Collaborate with cross-functional teams to ensure products meet safety, efficacy, and quality standards throughout their lifecycle.
• Lead, mentor, and develop a team of technical staff, fostering a culture of continuous improvement.
• Oversee lifecycle changes for products, ensuring compliance with internal quality and technical requirements.
• Drive proactive risk management activities, including risk assessment and mitigation strategies.
• Develop and maintain strong relationships with internal stakeholders to facilitate effective technical support and product stewardship.
• Develop and maintain key performance indicators (KPIs) to measure and improve the effectiveness of technical product stewardship activities.

Requirements

• Bachelor's degree in engineering, life sciences, or related field; advanced degree preferred.
• 10+ years of experience in medical device engineering, combination product development, or related technical fields.
• Demonstrated experience in a leadership role managing technical product stewardship or related functions.
• Strong understanding of medical device and combination product development from early stage through launch and supply.
• In-depth knowledge of global regulatory requirements for medical devices and combination products.
• Strong understanding of risk management principles, including ISO 14971 and other relevant standards.
• Excellent communication and interpersonal skills.

Nice-to-haves

• Advanced degree (Master's or PhD) in a relevant field.
• Proven track record of driving continuous improvement and implementing best practices in technical support and product stewardship.