At ev3 we're committed to being the global market leader and preferred partner for patients and physicians in identifying endovascular technologies for coronary, peripheral and neurological applications. Creative, competent people with a passion for enhancing health care around the globe have driven our success. Join our R&D team in Irvine, CA as we grow by making a meaningful difference!
We have an excellent opportunity for a Manager of Process Development who will manage a staff of engineers and coordinate product development. Following are the responsibilities:
Oversee the planning, development, implementation, and improvement of manufacturing methods, processes, and equipment for new and existing products in accordance with existing ISO, GMP, and MDD requirements.
· Manage and ensure a high level of Lean Six Sigma, FMEA, statistical experimental design, project engineering, and quality standards necessary to deliver innovative processes in a timely manner.
· Assist in development of strategies concerning process/product development timelines, project priorities, and related departmental programs and budgets.
· Provide engineering resources for the support of new and existing products in Manufacturing, as needed.
· Ensure technical organization compliance with Operations strategic objectives.
· Hire, train and develop development engineering staff to ensure the adequate levels to achieve operational goal attainment.
· Other duties as assigned or required.
B.S. degree in mechanical engineering or similar discipline; Master’s Degree preferred
Experience: 8 years engineering experience with 3 years in a supervisor or management capacity.
Other Skills:
- Knowledge of process development for medical device products
- Project management and previous budget responsibility.
- Hands on, self-directed, and continuous improvement and results oriented.
- Strong analytical, problem solving, and communication skills required.
- Lean Six Sigma experience and implementation skills.
- Must have strong organizational and planning skills.
- Commitment to a culture of continuous improvement.
ev3, Neurovascular has an excellent benefits package including a matching 401K plan. Please apply online to www.ev3.net. We are an Equal Opportunity Employer.
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