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Engineer II
Ref No.: 18-12565
Location: St. Paul, Minnesota
Start Date / End Date: 10/15/2018 to 10/14/2019
Engineer (focused in design)
Business Unit Advanced Surgery products

This position is responsible for supporting the activities of the Design Owning Organization (DOO) at the St. Paul, MN facility. The candidate will work with the St. Paul Product Design Owners (PDOs) in performing tasks related to regulatory compliance, change control, design control, and risk management for Advanced Surgery products produced under the St. Paul and MCA DOOs.

Essential Duties and Responsibilities
• Support the PDOs in fulfilling requirements for regulatory compliance, design control and risk management activities for Advanced Surgery produc
o Help ensure that design and development activities and documentation are within regulatory compliance, particularly for the new European Medical Device Regulation (MDR)
o Help maintain the Design History Files and Risk Management files for St. Paul and MCA products
o Generate and manage work flow for appropriate change control documentation.
• Support the PDO in gathering information from Subject Matter Experts (SMEs) and technical resources for complaint trending, complaint investigations, non-conformance investigations, change control, and regulatory submissions
• Other tasks as needed

Qualifications:
• Solid communication skills – both written and oral
• Organizational skills and attention to detail
• Ability to work effectively independently and in team environment.
• Experience working in medical device development, design control and risk management is required.
• Knowledge and experience working with medical device regulatory requirements, DHF remediation, and change control desirable.

Education / Experience
Bachelor's degree in a scientific or engineering discipline with 3-5 years’ work experience
Software: Word, Excel (pivot tables, v-lookups, reporting), PowerPoint, SharePoint, Outlook
Medical Device Industry experience required

Physical
• Regular attendance is necessary to perform the essential functions of the job.
• Sedentary work, lifting a max of 10 lbs; walking/standing occasionally.

Work Environment:
• Normal office working conditions: computer, phone, files, fax, copier.

Interview platform: phone followed by onsite interview (at least an onsite interview)