Title: Development Engineer
Pay: $50.00 - $54.62
Hours: Monday–Friday; 8AM–5PM
Location: Hybrid – 3 days onsite / 2 days remote
Colorado Springs, CO 80921 or Plymouth, MN 55442 (preferred)
Overview
This role supports the accuracy and quality of product labeling and packaging for Image Guided Therapy (IGT) medical devices. Responsibilities include creating and maintaining Instructions for Use (IFUs) and product labels while ensuring compliance with GMP, FDA, ISO, and internal quality standards. The role requires strong attention to detail, collaboration, and a first-time-right mindset.
Key Responsibilities (Simplified)
* Create and update IFUs, including layout, illustrations, and written content.
* Develop or revise labeling artwork using approved tools (e.g., Bartender, Adobe LiveCycle, EnLabel).
* Use Windchill (PLM) to route documents, track revisions, and manage approvals.
* Complete prepress tasks and prepare artwork files for accurate production.
* Assemble and route labeling packages for review and approval.
* Proofread labeling and verify accuracy using measurement tools and barcode scanners.
* Maintain proper revision control, documentation, and compliance with quality system requirements.
* Work with cross-functional teams to resolve issues (NCRs, CAPAs), conduct root-cause analysis, and support long-term solutions.
* Follow and contribute to continuous improvement processes.
Desired Skills (Highlighted for Clarity)
Technical Skills
* Adobe Creative Suite (required)
* Microsoft Office (required)
* Adobe LiveCycle (preferred)
* Bartender, EnLabel, Windchill, SAP (plus)
* Ability to learn new software quickly
* Understanding of medical device regulatory standards (FDA, EU MDR, ISO, Canada, Japan)
Professional Skills
* Strong attention to detail
* Excellent written and verbal communication
* Strong prioritization and time-management skills
* Independent judgment and problem-solving abilities
* Ability to work effectively with cross-functional teams, including senior leadership
* Adaptability to changing processes or technical requirements
Education Requirements
* Bachelor’s degree or equivalent relevant work experience
Benefits
* Health insurance
* Health savings account
* Dental Insurance
* Vision Insurance
* Flexible spending accounts
* Life insurance
* Retirement plan
All qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
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