Sr. Engineer, Product Sustaining

5 - 7 years experience  • 

Salary depends on experience
Posted on 03/20/18
Orange, CA
5 - 7 years experience
Salary depends on experience
Posted on 03/20/18

Job ID: KAV001349

About Us

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.

Description

Position Overview:

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.  


Qualifications

Qualifications:

    • 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 

Preferred:
•    -  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

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