Sterile Packaging Engineer

Job Description

SUMMARY: Red Star Contract Manufacturing is a vertically integrated facility in Larwill, Indiana. With expanded capabilities in injection molding, prototyping, and sterile packaging, we offer convenience and quality products to the customers we serve. Red Star is hiring a Sterile Packaging Engineer to support business growth and our new building expansion.

The position of Sterile Packaging Engineer is responsible for the creation of validation protocols, technical justification rationales, procedures, instructions, and forms that affect cleaning, sterile packaging, clean room monitoring, sterilization, and biocompatibility according to Medical Device Standards for use by Red Star Contract Manufacturing and customers. This position works cross-functionally with quality, manufacturing, and supply chain partners from DHF (Design History File) development to design transfer of DMR (Device Master Record) and then through manufacturing, sterile packaging, sterilization and to shelf DHR (Device History Record). The primary focus is to support the sterile packaging division and ensure that each sterile packed kit meets all requirements for biocompatibility and that the packaging withstands both shelf life and distribution testing.

ESSENTIAL DUTIES AND RESPONSIBILITIES: (includes the following but other duties may be assigned)

BOM's and DFEMA's for correlation of critical features in design for sterile packaging during design transfer

Design transfer activities including development of Control Plans with Supplier, ensuring all critical parameters captured and controlled according to process risk and capability

All new products, packaging, or process changes to mitigate any potential increased risk for sterility and packaging integrity

Ensure through audit that validations are current and complete with each sterile packaging facility

Protocols are written to Medical Device Standards and the execution of the validations are complete without any open non-conformance

Monitor and manage biocompatibility with product development, suppliers, and sterile packaging facilities

QUALIFICATION REQUIREMENTS:

Bachelor's Degree in engineering-related field, preferably in sterile packaging engineering

Understanding of quality control, manufacturing, validation, and statistics in a medical device setting

OTHER SKILLS and ABILITIES:

Proficient in creative problem solving and communication

Proficient in Microsoft Office

Project planning experience

Self-motivation

BENEFITS:

Competitive Paid Time Off

Paid Holidays

Group Medical Coverage

Dental/Vision Coverage

Short-Term and Long-Term Disability

401K Retirement Plan