Senior Packaging Engineer
Leading Medical Device manufacturing Company- Benefits offered
This individual will support activities ranging from New Product Introduction (NPI), design changes on legacy products on a portfolio of products (30+) and remediation activities for newly acquired products and key corporate projects (such as, EU MDR). Key activities include:
1. Execution of the Packaging Testing, authoring and/or editing Packaging test protocols and reports and managing the Label Design process.
2. Be responsible and participate in continuous improvement and assessment of current procedures and identify best practices.
3. Support audits, non-conformances and CAPAs as needed.
4. Work with drafter to develop 3D models and Artwork of packaging components and accessories.
5. Be required to demonstrate PDP/TDP system knowledge through delivery of high quality deliverables.
6. Coordinate and track the execution of all associated design deliverables for a change from other cross-functional representatives – Design Quality, Regulatory Affairs, Supplier Quality and Operations.
7. Build Quality into all aspects by maintaining compliance to all quality requirements and leading improvements that make it easier for the organization to maintain compliance in complex areas.
8. Lead small- scale Packaging/Labeling projects.
9. Be required to have a high level of service and responsibility in managing a high and varied workload from internal.
1) Ability to coordinate and execute a “high” workload in a regular cadence.
2) Project Management / Project Coordination / Thrive in fast paced Team environment
3) Proficient in Technical writing (Medical Device Quality System deliverables).
4) A high level of detail orientation
5) Proofing experience (Graphics and Text)
6) Experience with Task or Job Tracking 7) Service orientation
8) Familiarity with Packaging Engineering Testing (11607 / ISTA/ASTM).
9) Proficiency with MS Word and MS Excel
10) Familiarity with MS Project / MS Visio / Adobe InDesign or Illustrator
11) Knowledge of PLM/PDM systems and Change requests
12) 3-5yrs with Packaging Engineering
13) 3-5yrs with Project Management