Hybrid Development Engineer

at ELYON International

• Job title: Development Engineer
• Job type: Contract
• Experience level: Mid level, Senior
• Salary: $50 per hour
• Degree requirement: Bachelor's Degree
• Location requirements: Hybrid, Colorado Springs, United States

About the role

• Development Engineer maintaining quality documentation for Image Guided Therapy devices. Collaborating across departments ensuring adherence to regulatory standards and approval processes in a hybrid work environment.

Responsibilities

• 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.

Requirements

• 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.

Benefits

• Paid sick leave
• Medical/Dental (optional)
• 401 (k) Retirement Plan (optional)
• Employer Paid Life Insurance
• Employer Paid Short Term Disability
• Optional Life Insurance