With 1,500 employees, 14 production sites, and 23 logistics and sales sites across 3 continents, Sterimed is the world leader in sterilization packaging solutions for medical devices. Sterimed develops, produces, transforms, and markets various types of solutions (bacterial barriers and pre-formed sterilization packaging) for both hospitals and medical device manufacturers.

As an LBO group, Sterimed is characterized by a strong entrepreneurial DNA and has pursued a very dynamic external growth policy for several years. Since its founding in 2016, the size of the group has increased 4.5 times, and 10 acquisitions have been made since 2017.

The position is based at Ridgeville, our brand-new facility, providing a dynamic and stimulating environment that offers ample opportunities to innovate and contribute to the company’s growth.

Sterimed is expanding its U.S. contract packaging capabilities and is seeking a high-impact Project Engineer to lead the technical establishment and scale-up of our new Contract Packaging activities at our Ridgeville, South Carolina site.

This is a hands-on, growth-oriented role where you will act as the technical bridge between commercial, operations, quality, and our Riverside Medical UK team. You will be instrumental in converting customer opportunities into fully operational, validated manufacturing programs.

Key Responsibilities

Program Development

• Lead the transfer of contract packaging processes from Riverside Medical (UK) to Ridgeville, SC.
• Develop and maintain SOPs, process routings, BOMs, line rates, labor models, and capacity models.
• Translate customer requirements into executable production workflows.

SOPs, Validation & Quality Integration

• Author and implement SOPs, work instructions, process flow diagrams, PFMEAs, control plans, and validation documentation (IQ/OQ/PQ).
• Ensure all processes meet FDA, ISO 13485, cGMP, and Sterimed Quality System requirements.
• Support audits, customer site visits, and technical due-diligence meetings.

Quotation & Commercial Support

• Support the commercial team with:
• Technical inputs for quotations (line rates, labor, materials, CapEx, yield assumptions).
• Feasibility assessments and manufacturability reviews.
• Lead the conversion of approved quotations into:
• Production-ready routings
• Capacity commitments
• CapEx justifications and ROI models

Project Management & Customer Onboarding

• Act as technical project lead for new customer programs from award through first commercial shipment.
• Develop and manage:
• Project plans
• Risk registers
• Timelines
• Gate reviews
• Serve as the technical interface for customers during onboarding, line trials, and ramp-up.

Required Qualifications

• Bachelor’s degree in Mechanical, Manufacturing, Industrial, or Packaging Engineering (or similar).
• 4+ years of experience in medical device manufacturing, contract packaging, or regulated manufacturing environments.
• Proven experience with:
• Validation (IQ/OQ/PQ)
• SOP development
• Strong working knowledge of ISO 13485, cGMP, FDA QSR.
• Comfortable in a fast-growth, build-from-scratch environment.

Preferred Experience

• Background in sterile barrier systems, cleanroom packaging, pouching, thermoforming, or tray sealing.
• Experience supporting quotations and cost modeling in a contract manufacturing environment.
• Exposure to international technology transfer projects.
• Familiarity with Lean / Six Sigma methodologies.

What We Offer

• International training at Riverside Medical (UK).
• A unique opportunity to help build and scale a new business unit from the ground up.