Manager, Mechanical Engineering
ColoplastAbout the role
This position is a member of the innovation department and is responsible for leading and developing the mechanical engineering discipline. This position will serve as a technical resource to project teams on various Interventional Urology Implantable Devices (IU ID). In addition, the manager is responsible for supporting and training their staff, as well as mentoring, team development and implementation of retention strategies.
Major Areas of Accountability
- Lead and continuously improve implementation of mechanical engineering first principles
- Responsible for development and implementation of methods and procedures for detailing and documenting design decisions
- Involved with creating schedules by supporting their team members in understanding the tasks, interconnections, and dependencies, while guiding alternate scenarios to completion
- Implement risk-based decision-making approaches to support engineering timelines
- Communicate with internal customers to understand the needs of the organization and develop a strategy and vision to support those needs
- Build upon the leverage of having an internal specimen lab as it supports designs and test methods
- Manage direct reports, ensuring duties, responsibilities, authority, and expectations for direct reports are defined and understood
- Improve team performance with cohesiveness by leading, influencing, training, and motivating to facilitate cooperation, ensure efficiency, boost morale and drive success
- 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 in mechanical or related engineering discipline
- 7+ years in an engineering role
- 3+ years in a medical device research and development environment
- Strong statistical background
- Experience with Class II and Class III implantable medical devices
- Able to travel, both domestic and international, as required
Required Knowledge, Skills and Abilities
- Excellent verbal and written English communication skills
- Experience mentoring and training a team of engineers. Previous experience managing a team of direct reports preferred.
- Excellent analytical and problem-solving skills
- Experience with FDA regulations (21 CFR Part 820), ISO standards (13485, 14971), & EU MDR
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Pursuing an ambitious growth agenda, Coloplast develops and markets products and services that make life easier for people with intimate healthcare needs. Employing about 14,000 people and with products available in more than 143 countries, we are one of the world´s leading medical device companies. We are constantly growing our business and always looking for new ways to move forward – we explore, learn and look for new ways of doing things.
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Coloplast is committed to a policy of Equal Employment Opportunity (EEO) which means we employ and promote individuals based on their merits, regardless of race, color, religion, sex, national origin, age, disability, veteran status, pregnancy, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status, status with regards to public as
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