Development Engineer

Description:

Hybrid Role - 3 day in and 2 remote.

Locations would be Colorado Springs or Plymouth, MN (preferred).

In this role, you have the opportunity to

Bring your passion and energy into a growing department dedicated to the quality output of product labeling and packaging for Image Guided Therapy (IGT) devices in accordance with GMP s, FDA Regulations, EUMDR, ISO Requirements and Standard Company Operating Procedures.

You are responsible for

• Develop and maintain Instruction For Use (IFUs) documents, including product illustrations, layout design, and illustrative material and copy.
• Utilize existing templates in programs including, but not limited to, Bartender, Adobe LiveCycle and EnLabel to create or revise labeling artwork and content based on corporate graphic standards, procedures and/or previously established formats.
• Use of PLM (Windchill) for document control process to route all work for approval
• Perform prepress activities necessary to prepare labeling artwork files for accurate output.
• Prepare and route labeling packages for 1st article and approvals.
• Proofread labeling artwork utilizing measurement, inspection tools (e.g. rulers, barcode scanner, etc.) and related documentation. This is a quality role in medical devices which focuses on a first-time right approach. Attention to detail with minimal errors is key.
• Reviews and updates as necessary to ensure proper revision control and storage of all labeling.
• Establishes and cultivates a network of support (manufacturing, engineering, regulatory, legal, product development and marketing) to facilitate completion of labeling and artwork assignments.
• Can successfully work with cross-functional teams to address NCRs and CAPAs. Investigate, analyze, and identify root cause. Evaluate underlying issue and find long-term solutions.
• Maintains and follows proper compliance and quality system requirements. Ensures proper documentation is prepared and corrected to reflect continuous improvement activities that lead to new or improved processes.

To succeed in this role, you should have the following skills and experience

• Bachelor s degree or equivalent relevant experience required
• Proficient in Adobe Creative Suite and Microsoft Office
• Experience with Adobe Lifecycle is preferred
• Exposure to Bartender, EnLabel, Windchill and/or SAP is a plus
• Knowledge of Regulatory standards (FDA, EU MDR, Japan, Canada, ISO standards) is preferred
• Excellent written and verbal communication skills
• Ability to exercise independent judgment consistent with company policy
• Ability to organize and prioritize workflow
• Ability to interact with all levels of employees including senior management
• Ability to adapt to changing processes and learn programs/software quickly
• Strong attention to detail is critical