Job Description
Job Description
Job Description
Job Summary
The 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.
Location: Wilmington, MA
Salary range: $105,000 - $120,000 + bonus
Duties and responsibilities - Develop and maintain strong, internal working relationships across both North and South restor3d facilities
- Understand the objectives, responsibilities, and mission of the Engineering department and work towards those goals
- Prioritize and plan work activities; adapt for changing conditions
- Initiation, execution, and documentation of IQ, OQ, & PQ activities
- Optimization of manufacturing processes (5S) for Lean Manufacturing
- Day-to-day Cleanroom packaging production support activities such as NCMRs and CAPAs
- Processing of documentation change requests from originator to final approval
- Writing and executing process validation plans and reports, using sound, data- & stats-supported results
- Using Statistical tools for alternative material evaluations and validations projects
- Support of material handling and control system
- Help conduct time studies and process flow mapping
- Assure compliance with the requirements set forth by US FDA QSR and ISO regulations
- Interpret standards and FDA requirements for device packaging and validations
- Apply sterilization requirements/standards to packaging design and validation
- Work cooperatively with process development, quality, manufacturing, regulatory, and marketing to ensure project success
- Documentation of manufacturing packaging processes and inspection criteria within the company’s documentation procedures
- Evaluate and recommend capital packaging equipment to best suit the needs of the company’s selected fabrication processes
- Participation on project teams as a contributor bringing proactive solutions and execution
- Other responsibilities as assigned
Qualifications and experience Required Skills: - Excellent written and verbal communication skills
- Able to work accurately in a fast-paced, hectic, ever-changing environment with strong attention to detail
- Demonstrated ability to monitor own work to ensure quality, accuracy, and thoroughness
- Strong organizational, analytical, and time-management skills
- Able to self-motivate and work both independently and as part of a team
- Understanding of ISO 13485 and QSR regulations
- Knowledge of statistical analysis
- Knowledge of computer added design (SolidWorks preferred)
- Ability to work independently as well as on teams to perform root cause analysis and provide solutions to the root cause.
Education and Experience: - Bachelor’s Degree in an Engineering discipline
- 5-7 years previous experience in an FDA regulated industry required: medical device, pharmaceuticals, biotech, and/or life sciences; orthopedics experience preferred.
- Experience in EO and VHP Sterilization modalities
- Experience working ISO Class Cleanrooms or Controlled Environments
- Prior experience documenting manufacturing processes and creating Work Instructions and Standard Operating Procedures for a high-volume production floor
- Prior experience in just-in-time manufacturing or prototype development preferred
- Working knowledge of MS Word, Project, PowerPoint, and Excel, AutoCAD or SolidWorks preferred
Preferred education and experience: - Bachelor’s Degree in Packaging Engineering
- Master of Engineering Degree strongly preferred
Physical Requirements: - Prolonged periods sitting at a desk and working on a computer
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