Staff Packaging Engineer: Surgical Robotics – OTTAVA
US328 CA Santa Clara - 5490 Great America Pkwy, United States
USD 118K-203K Senior-level Full Time
Tasks
- Collaborate with cross-functional teams and suppliers
- Conduct distribution simulation testing
- Design primary secondary tertiary and transport packaging
- Develop SOPs and work instructions
- Develop packaging specifications drawings and bills of materials
- Drive continuous improvement and sustainability initiatives
- Ensure packaging documentation traceability in DHF and DMR
- Ensure packaging regulatory compliance
- Execute engineering changes in PLM systems
- Execute packaging testing and validation
- Lead packaging design and development
- Manage packaging labeling UDI and global requirements
- Perform accelerated aging studies
- Perform structural design and cushioning design
- Select packaging materials for medical devices
- Support IQ OQ PQ execution
- Support regulatory submissions and audits
- Support supplier qualification and packaging trials
Perks/Benefits
- N/A
Skills/Tech-stack
21 CFR part 820 | ASTM | Accelerated Aging | Bills of Materials Management | Bills of materials | Blocking and Bracing | CAD | CFR Part 820 | Change Control | Compression testing | Corrugated Materials | Cushioning | DHF | DMR | DOE | Distribution testing | Drop testing | ECO management | EDI not included | Engineering Change | Engineering Change Control | FDA 21 CFR | FDA 21 CFR Part 820 | FDA QSR | Foam | IQ/OQ | IQ/OQ/PQ | ISO 13485 | ISO 14971 | ISPM 15 | ISTA | Labeling compliance | Material selection | Materials Management | Medical Devices | OQ PQ | PLM | Packaging design | Part 820 | Plastics | REACH | RoHS | Sampling plans | Shock testing | SolidWorks | Structural Design | Sustainability | UDI | Validation | Vibration testing
Education
Bachelor of Engineering | Bachelor of Science | Master of Science
Regions
Countries
States
Cities
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