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Process Engineer I

Job Title: Process Engineer I
Job Id: 7244
Location: Boulder CO 80301
Duration: 7+ Months
Shift Hours: 8-5pm - flexible schedule - could work remote from time to time. Need to be in CO

Summary of position:
The Process Development Engineer will develop, define and document processes for the Professional Services and Strategic Alliances organizations. This includes a combination of technical, business and service activities that occur within the framework of FDA Quality System Regulations and under FDA Design Controls. This position requires an understanding of application software installation, training and service processes, and work flows associated with Patient Monitoring equipment. The Process Development Engineer will also be responsible for leading an established technical service call center.

Essential functions:
1.Participate in cross functional teams.
2.Develop and document technical and business processes.
3.Track process development progress against plan.
4.Identify process improvements and optimizations.
5.Identify process risks and provide plans to mitigate those risks.
6.Regularly report progress to management.
7.Lead technical service call center.

Department Specific/Non-Essential Functions:
Other duties as assigned with or without accommodation.

Minimum Requirements:
Bachelors degree in Science or Engineering required.
Advanced degree preferred.
Three years of Process Engineering experience with progressively increasing responsibilities.
Proven track record of defining and documenting complex technical and business processes.
Process development experience in a highly regulated environment.
Preferred Skills/Qualifications: Medical device development preferred.
Familiarity with FDA Design Control Guidelines.
Experienced with Microsoft Project, Visio and MS Office.
Skills/Competencies: Strong interpersonal skills. Comfortable working with business partners and diverse team members.
Must be proficient in both written and oral communication skills.
Normal office conditions, with some travel (
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