Job Description Job description:
- Lead sustenance activities on packaging and labelling solutions for existing sterile and non-sterile implants and instruments with focus on EUMDR requirements Drive continuous improvement and assessment of current procedures identify best practices.
- Develop packaging and labelling components that improve the customer experience, 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 centres - 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/Labelling 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
- Bachelor's degree in Packaging, Industrial, Mechanical engineering, or applicable technical field. 7+ years of experience in medical device industry is preferred
- Demonstrated experience in medical device, biotech or pharmaceutical packaging design development. Demonstrated experience in resolving design and process related packaging issues on commercial products
- Functional knowledge of Design Controls and Industry standards in Packaging Design. (11607, ASTM, ISTA) Knowledge in Labelling Systems and label and IFU development Experienced in Statistical Analysis, interpretation, and communication of results Excellent interpersonal and communication skills
- Strong technical capabilities and project management capabilities to develop aspects of assigned projects on time and within budget
: 22-01420 : South Plainfield, NJ: