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Medical Device Packaging Engineer
Fremont, CA 94538 US
The R&D Packaging Engineer will be a member on the Sustaining Packaging project teams with responsibilities for design and development of packaging components and artwork design, design verification, shelf-life testing and label design.
Position Description (Principle Duties and Responsibilities)
- Support EU MDR execution and implementation on Neurovascular products.
- Design and develop best in class packaging and labeling solutions from early concept through commercialization for sterile and non-sterile medical devices.
- Drive continuous improvement and assessment of current procedures and Voice of the Customer input and identify best practices.
- Develop packaging and labeling components that improve the customer experience, working with a drafter to develop 3D models and Artwork.
- Demonstrate development life cycle knowledge through delivery of high-quality deliverables.
- Work cooperatively with quality, manufacturing, regulatory, clinical, marketing, R&D device designers, supply chain, vendors, and kitting centers ? across geographies -- to ensure project success.
- Build Quality into all aspects of product development and support by maintaining compliance to all quality requirements and leading improvements and development of solutions that make it easier for the organization to maintain compliance in complex areas (such as ever-evolving regulatory requirements worldwide).
- Support audits, non-conformances and CAPAs as needed.
- Lead small- scale Packaging/Labeling projects or co-manage large-scale programs to drive changes across the portfolio.
- Mentor or supervise technical staff as needed.
- Role-model a high level of service and responsibility in managing a high and varied workload from internal clients and working to tight timelines.
- B.S. degree in Packaging, Industrial, Mechanical engineering, or applicable technical field.
- 4+ years (minimum) of experience in a highly regulated industry, with relevant experience in design and developing best in class packaging and labeling solutions from early concept through commercialization for sterile and non-sterile medical devices.
- Demonstrated experience in medical device, biotech, or pharmaceutical packaging design development desired.
- Demonstrated experience in resolving design and process related packaging issues on commercial products.
- Functional knowledge of Design Controls and Industry standards in Packaging Design and Testing (ISO, ASTM, ISTA)
- Knowledge in database driven Labeling Systems, label and IFU development.
- Experienced in Statistical Analysis, interpretation, and communication of results.
- Excellent interpersonal and communication skills
- Strong technical and project management capabilities to develop aspects of assigned projects on time and within budget.
- Microsoft applications (Word, Excel, PowerPoint, and Visio)
- Adobe Suite (InDesign, FrameMaker, Photoshop, and Illustrator)
- Database driven labeling system such as Prisym, Label View, Loftware, BarTender, NiceLabel, and Easy Label
- Computer Aided Drafting (CAD) - Solidworks, AutoCAD