The Packaging Engineer will be responsible for and/or assist in the design, testing and validation of sterile and non-sterile packaging for medical products for the Global Packaging team. Package design activities include risk analysis, design input, design output, design verification and validation, and design transfer per the Design Control policies and procedures, and adherence to all applicable global package integrity and protection standards. Support process development, validation and implementation activities within manufacturing sites, contract manufacturers or strategic suppliers as required. Assist or lead updates to the product device master records (DMR), design history files (DHF) or internal SOPs/Work Instructions in compliance with the Quality System.
location: Morrisville, North Carolina
job type: Contract
salary: $51 - 54 per hour
work hours: 9 to 5
- Perform gap assessment on legacy product packaging documentation for gaps against ISO 11607
- Assist packaging development engineers and R&D teams to re-mediate and develop medical device packaging, specifications and processes.
- Assist and perform with project management, project tracking and communication on MDR related project work.
- Based upon gap assessment and remediation work required, perform following duties under supervision of packaging engineering personnel:
- Aid in the redesign of existing packaging systems and manufacturing processes to improve quality, utilize automated production techniques, optimize process capabilities, and produce better products in a more cost-effective manner.
- Interface with suppliers, Strategic Sourcing, R&D, Marketing, Quality and Regulatory Affairs to deliver projects as appropriate.
- For in-house manufactured and purchased packaging systems/components, assist in the design control activities for the new/replacement and existing product packaging and components.
- Assist with and coordinate the development/improvement of packaging design & processes by utilizing tools such as DOE and statical analysis; assist in implementation with appropriate controls and metrics.
- Conduct or coordinate package testing in the internal Packaging Lab or with external testing services providers.
- For both in-house and purchased packaging systems/components, coordinate the transfer of parts, assemblies, documentation and processes from prototype stage, through pilot to production. Generate product, process and experimental activity specifications for the Device Master Record as required.
- Aid the project teams in meeting project objectives, milestones, and target dates. Update and review project progress on an as-required basis by supervisor.
- Direct efforts of draftsmen, technicians, tradesman, and lab personnel in the development of packaging related products, processes, test fixtures, equipment, test procedures and documentation.
- Ensure projects are developed and documented compliant with the Quality System.
- Adhere to and ensure the compliance of Code of Ethics, all Company policies, rules, procedures and housekeeping standards.
- Self-motivated, high energy, collaborative, positive attitude individual with the initiative and drive for timely completion of goals.
- Able to travel domestically and internationally.
- Strong analytical and problem solving skills.
- Package testing and design knowledge highly preferred.
- Effective verbal and written communication skills.
- Team player with good interpersonal skills.
- Proficient in Microsoft Office Suite and computerized analysis applications.
skills: Medical Device Product Development
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.