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 R and D quality regulatory manufacturing procurement and logistics teams
- Contribute to SOPs work instructions and continuous improvement
- Design and develop primary secondary tertiary and transport packaging
- Develop packaging specifications drawings and bills of materials
- Ensure compliance with labeling UDI ISPM 15 RoHS and REACH
- Ensure packaging compliance with FDA QSR and ISO 13485
- Ensure packaging documentation within DHF and DMR
- Execute packaging structural design and cushioning concepts
- Execute packaging testing and validation per ASTM ISTA ISO and internal procedures
- Optimize materials reduce waste improve logistics and increase recycled content
- Perform distribution simulation drop vibration compression shock and accelerated aging
- Provide technical leadership for packaging design and development
- Select packaging materials and perform blocking and bracing design
- Support FDA and Notified Body audit activities
- Support IQ OQ PQ execution
- Support cost quality and sustainability initiatives
- Support regulatory submissions packaging content
- Support supplier qualification packaging trials and engineering change execution
- Use PLM systems for ECO management
Perks/Benefits
- N/A
Skills/Tech-stack
ASTM Standards | CAD | Change Order | DHF | DMR | DOE | Device packaging | Distribution testing | ECO management | Engineering Change | Engineering Change Order | FDA QSR | IQ/OQ | IQ/OQ/PQ | ISO 13485 | ISO 14971 | ISO Standards | ISPM 15 | ISTA standards | Labeling | Medical Device | Medical Device Packaging | OQ PQ | PLM | Packaging design | REACH | Recycled Content | Regulatory Compliance | RoHS | Sampling plans | SolidWorks | Statistical Sampling | Sustainability | Testing and Validation | UDI
Education
Bachelor of Engineering | Bachelor of Science | Master of Science
Regions
Countries
States
Cities
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