Sr Process Development Engineer

At ev3 we're committed to being the global market leader and preferred partner for patients and physicians in identifying and treating lower extremity arterial and neurovascular disease through innovative, breakthrough, and clinically proven technologies.  Through talented and motivated employees, our commitment to rapid innovation and a personal touch, we work in close collaboration to deliver high quality products and services.

Creative, competent people with a passion for enhancing healthcare around the globe have driven our success. Join us as we grow by making a meaningful difference.

We are currently seeking two Sr Process Development Engineers. This position will work closely with R&D and Manufacturing Engineering in the development of new products and the processes necessary to produce these products in a lean manufacturing environment. Implement and qualify production equipment and methods, generate testing protocols and reports, and work with minimal direction. RESPONSIBILITIES:  Leads the development of highly capable manufacturing processes for new and existing products through frequent interaction with R&D, Manufacturing and Quality Engineering, and Production Operations Develops and coordinates the execution of process characterization and validation plans.  Supports manufacturing continuous improvement projects. Ensures all Process Development Engineering elements of the PDP for new products meet the needs of each group within operations. Provides mentoring for more junior technical staff. May have supervisory responsibility for technician staff. Comply with applicable FDA and international regulatory laws/standards and the ev3 Code of Conduct. Other duties as assigned or required

 

This position is located at our manufacturing facility in Plymouth, MN.

We offer competitive compensation, generous benefits, and the opportunity to improve the lives of people everywhere. For consideration, please apply online at www.ev3.net. No phone calls please. Equal Opportunity Employer/ Affirmative Action Employer.

Job Requirements:
MINIMUM QUALIFICATIONS:   Education:  · BS or MS degree (Mechanical, Biomedical, Engineering, or related technical field) with 5 to 9 years of experience.   Experience:  · Proficient in design and process FMECA, Process Validation and variability reduction applications. · Experience with medical device based products and processing and technologies. · Good verbal and written communication skills. · Implementation and support of Lean Manufacturing, Demand Flow, Total Quality tools. · Application of statistical and analytical methods such as SPC, SQC, and DOE. · Process background (development, capability, optimization, validation) within a regulated industry. · Development of manufacturing documentation (MP, IP, BOM) · Development and qualification of tooling/equipment (IQ/OQ/PQ, support, design) · Project management associated with new process/product development and the successful transfer into manufacturing. · Manufacturing continuous improvement support · Test protocol generation, execution, and reporting  · Coating process experience or Materials Engineering experience preferred. · Medical Device/Pharmaceutical Industry experience preferred. · Laser welding experience preferred.Job Code : 713 Division/Department : CARDI Travel Required : None Skills : Engineering -> Process/Process Control