What are the responsibilities and job description for the Design Engineer position at Fusion Life Sciences Technologies LLC?
Job Title: Design Engineer
Location: Warsaw, IN (onsite)
Key Responsibilities:
- Review and remediate Design History Files (DHFs) for acquired product lines.
- Update and manage design documentation within Zimmer Biomet's "The Vault" system.
- Work with cross-functional teams, including quality, regulatory, and manufacturing, to align documentation with current standards.
- Ensure compliance with FDA, ISO 13485, and EU MDR regulations.
- Conduct gap assessments and implement corrective actions for missing or outdated design documentation.
- Develop and revise engineering drawings, specifications, and risk management files as needed.
- Maintain design control requirements and traceability throughout the remediation process.
- Support Change Control (CC) and Engineering Change Orders (ECOs) related to the DHF updates.
- Participate in design reviews and provide technical expertise in regulatory compliance.
Qualifications & Experience:
- MUST HAVE: Prior experience working at Zimmer Biomet and using "The Vault" system.
- 3-7 years of experience in medical device design engineering.
- Strong knowledge of DHF remediation, design controls, risk management, and verification/validation processes.
- Familiarity with FDA 21 CFR Part 820, ISO 13485, and EU MDR compliance.
- Experience with engineering documentation, product lifecycle management (PLM), and CAD software.
- Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, or related field.
- Ability to work independently in a fast-paced environment with minimal supervision.
