Manager, Process Development

The Manager, Process Development will act as manager and technical lead for the process development efforts and associated team.  This position is responsible for acting as a technical guide for projects with respect to the process development process and function as an expert in this area.  In addition, the Manager is responsible for supporting and training the process development staff, as well as mentoring, team development, and implementation of retention strategies.

Major Areas of Accountability

• Lead and continuously improve all process development efforts
• Communicate with internal customers to understand the needs of the organization and develop a strategy and vision to support those needs
• Manage direct reports, ensuring duties, responsibilities, authority, and expectations for direct reports are defined and understood
• Provide Work Breakdown Structures into project timelines with commitments that are aggressive and achievable.
• Implement visual management solutions to highlight major tasks and milestones that the team is working towards.
• Manage and develop team performance with cohesiveness by leading, influencing, training, and motivating to facilitate cooperation, ensure efficiency, boost morale and drive success
• Responsible for development and implementation of procedures for process development in the overall product development process
• Create, deploy, and monitor appropriate metrics to drive utilization and efficiency
• Conduct and complete process development tasks in support of projects
• Ensure good documentation and data retention practices are followed and maintained
• Support internal and external audits, as needed
• Conforms with Coloplast Code of Conduct and all local Compliance Standards
• Conforms with Coloplast Q/EHS Policy
• Other duties as assigned.

Basic Qualifications

• Bachelor's degree from a four-year college or university in a relevant science or engineering discipline
• 7+ years related experience and/or relevant training
• Experience managing a team of direct reports
• 5+ years in a medical device development or manufacturing environment required
• Strong statistical background
• Experience with Class II and Class III implantable medical devices is desired
• Able to travel, both domestic and international, as required

Knowledge, Skills and Abilities

• Excellent verbal and written English communication skills
• Ability to directly manage and develop a team
• Excellent analytical and problem-solving skills
• Experience with FDA regulations (21 CFR Part 820), ISO standards (13485, 14971), & EU MDR