Manager Combination Products - Sustaining Engineering

Manager Sustaining Engineering

Regeneron is seeking an experienced and strategic Combination Products Sustaining Engineer to manage a team in addition to monitor, investigate, maintain and/or improve the quality and performance of commercial combination products. They will provide comprehensive leadership in engineering product management, regulatory compliance (design controls), and cross-functional collaboration with internal and external stakeholders, for the maintenance of commercial products.

A typical day for a Manager Sustaining Engineering might include:

• Implementing design changes to improve the quality of existing products and/or the customer experience.
• Assisting with customer complaint investigations to identify root cause.
• Performing design change assessments for changes to existing products.
• Maintaining Risk Management Files for existing products based on post marketing surveillance and manufacturing events.
• Facilitating design transfer of existing products to new manufacturing sites.
• Performing technical evaluations related to supplier and manufacturing changes.
• Integrating identified product performance enhancements to new product development.
• Providing technical guidance to sustaining engineers.
• Participating in cross-functional design teams to address design issues.
• Developing and maintaining key business partner relationships throughout Regeneron.

This role might be for you if you:

• Understand relevant FDA regulations, particularly 21 CFR Part 3 and 21 CFR 820.30.
• Have experience with design history file management (21 CFR 820.30).
• Possess strong project management and interpersonal skills and strong analytical and problem-solving capabilities.
• Can balance business objectives with technical constraints.
• Can work effectively across multiple functional teams.
• Seek out continuous improvements and collaborative opportunities to improve internal processes and stakeholder relationships.
• Have strong technical writing and oral communication skills.
• Targeted to have direct reports within the Sustaining Engineering organization, to support multiple combination products in commercial distribution.

To be considered for the Manager Sustaining Engineering you must be willing and able to work Monday-Friday, 8am-4:30pm. You must have a B.S in Engineering; Biomedical Engineering, Mechanical Engineering, Industrial Engineering is preferred. For various levels you must have the following:

• Associate Manager Sustaining Engineering: 6+years of relevant experience
• Manager Sustaining Engineering: 7+ years of relevant experience

Previous experience in manufacturing of medical devices and/or combination products is preferred. Previous supervisory/ people leadership experience is required. Level is determined based on qualifications relevant to the role.

$103,300.00 - $197,500.00