Senior Packaging Engineer

Job Summary:
The Sr. Packaging Engineer will be responsible for assisting with the design, selection, development, qualification, support and scale-up of production processes and equipment across different manufacturing departments.

This position develops new packaging as needed, assesses and resolves packaging problems, and works with vendors as needed. Process objectives are the high quality, high volume production of patient-tailored implants and associated instruments.

Essential Duties and Responsibilities:

1. Develop and maintain strong, internal working relationships across both North and South restor3d facilities
2. Understand the objectives, responsibilities, and mission of the Engineering department and work towards those goals
3. Prioritize and plan work activities; adapt for changing conditions
4. Initiation, execution, and documentation of IQ, OQ, & PQ activities
5. Optimization of manufacturing processes (5S) for Lean Manufacturing
6. Day-to-day Cleanroom packaging production support activities such as NCMRs and CAPAs
7. Processing of documentation change requests from originator to final approval
8. Writing and executing process validation plans and reports, using sound, data- & stats-supported results
9. Using Statistical tools for alternative material evaluations and validations projects
10. Support of material handling and control system
11. Help conduct time studies and process flow mapping
12. Assure compliance with the requirements set forth by US FDA QSR and ISO regulations
13. Interpret standards and FDA requirements for device packaging and validations.
14. Apply sterilization requirements/standards to packaging design and validation.
15. Work cooperatively with process development, quality, manufacturing, regulatory, and marketing to ensure project success.
16. Documentation of manufacturing processes and inspection criteria within the company’s documentation procedures
17. Evaluate and recommend capital equipment to best suit the needs of the company’s selected fabrication processes
18. Participation on project teams as a contributor bring proactive solutions and execution
19. Other responsibilities as assigned

Qualifications:

1. Bachelor’s Degree in Packaging Engineering required, Master of Engineering Degree strongly preferred
2. 5-7 years previous experience in a FDA regulated industry required: medical device, pharmaceuticals, biotech, and/or life sciences; orthopedics experience preferred.
3. Experience in CAD modeling
4. Experience in EO and VHP Sterilization modalities
5. Prior experience documenting manufacturing processes and creating Work Instructions and Standard Operating Procedures for a high-volume production floor
6. Prior experience in just-in-time manufacturing or prototype development preferred
7. Working knowledge of MS Word, Project, PowerPoint, and Excel, AutoCAD or SolidWorks preferred.
8. Ability to work independently as well as on teams to perform root cause analysis and provide solutions to the root cause.

Skills, Abilities, Competencies Required:

1. Excellent written and verbal communication skills
2. Able to work accurately in a fast-paced, hectic, ever-changing environment with strong attention to detail
3. Demonstrated ability to monitor own work to ensure quality, accuracy, and thoroughness
4. Strong organizational, analytical, and time-management skills
5. Able to self-motivate and work both independently and as part of a team
6. Understanding of ISO 13485 and QSR regulations
7. Knowledge of statistical analysis
8. Experience working ISO Class Cleanrooms or Controlled Environments
9. Knowledge of computer-aided design (SolidWorks preferred)

restor3d is an Equal Opportunity Employer