Lead Project Engineer (Medical Device – Contract Packaging)

STERIMED US is the American operation of the Sterimed Group, a global leader in sterile barrier systems and integrated medical packaging solutions serving the medical device, pharmaceutical, and life sciences industries. We combine global expertise with local responsiveness to help customers protect product integrity, simplify supply chains, and support regulatory compliance.

About the role

Sterimed is expanding its U.S. contract packaging capabilities and is seeking a high-impact Lead 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.

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.

Requirements

• 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.

Skills

• 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.

Benefits

• International training at Riverside Medical (UK).
• A unique opportunity to help build and scale a new business unit from the ground up.
• Paid Life Insurance - $50k coverage
• Paid Short Term Disability
• Paid Long Term Disability
• Health/Dental insurance benefits: 92.5% of the premium cost for employee and 50% of premium cost for spouse and dependents is paid by Sterimed.
• 401k with 100% employer match of contribution up to 6% of gross earnings - Eligible to enroll after 6 months of employment, with enrollment periods starting on either July 1st or January 1st.