Job ID: KAV001349
Kerr Corporation is part of KaVo Kerr, a global leader of premier dental solutions for endodontics, restoratives, treatment units, infection prevention, imaging, rotary and instruments. KaVo Kerr is a cohesive organization united to provide dental excellence and serve as a premier partner for the dental community with a common vision to help our customers, their patients and our own associates realize their potential.
The Sr. Engineer will initially be responsible for leading Kerr’s CE Technical File update project.
Essential Duties and Responsibilities:
- Initiate and scope the project, develop project team including internal and new hires.
- Develop process for the Technical File update to ensure efficiency, deliverable quality of the project
- Develop project plan and schedule with cross functional department to incorporate business strategy and needs.
- Provide technical guidance to direct subordinates and project core team members
- Leads cross functional team members to execute project and ensure deliverables meet requirements and complies with quality policies, procedures and practices
- Drive projects to completion: proactively and continuously manage ambiguity and risks, apply superior judgement and timely decision making.
- Demonstrate passion and sense of ownership with strong and clear accountability for the success of the team
- Drive cross-functional alignment and proactively manage resource utilization and resource risks.
- Lead/facilitate variety of meetings to ensure successful outcome; daily management, core team meetings, and reviews.
- Supervision of direct reports.
The Candidate Should:
- Possess track record driving projects to completion on time, within budget and in high quality.
- Possess demonstrated ability to work in multidisciplinary teams.
- Have strong working knowledge and experience with global medical device regulatory. requirements, standards and product design control.
- Possess personnel management skills and experiences. Be able to develop, motivate and enable direct reports to be successful.
- BS degree in Science and Engineering. Chemistry related fields are preferred but will consider other engineering degrees.
- Minimum of 6years of product development or product sustaining experience in medical device industry.
- 3+ years of risk management experience in medical device. Strong knowledge with ISO14971:2012
• - Hands on experience with creating CE Technical Files. Deep knowledge with -- Tech file requirements.
- Advanced degrees in a science and engineering discipline may be a plus
- PMP certification may be a plus
- Proficiency in using tool such as FMEAs