Lead Project Engineer – Contract Packaging M/F

Sterimed Infection Control; South Carolina; On-site; USD 70,000 - 90,000; Full time

Benefits offered by this job

International training at Riverside Medical (UK)

Paid Life Insurance – $50k coverage

Health/Dental insurance benefits

401k with 100% employer match

Job summary

Sterimed Infection Control in Ridgeville, South Carolina is seeking a high-impact Project Engineer to lead the technical establishment of new Contract Packaging activities. This growth-oriented role will act as the technical bridge among various teams and direct the conversion of customer opportunities into operational programs.

The candidate should have a Bachelor’s degree in relevant engineering fields and over 4 years of experience in medical device manufacturing. Key responsibilities include managing project plans, authoring SOPs, and ensuring compliance with FDA and ISO standards.

Qualifications

• 4+ years of experience in medical device manufacturing, contract packaging, or regulated manufacturing environments.
• Proven experience in validation (IQ/OQ/PQ) and SOP development.
• Strong working knowledge of FDA QSR and cGMP standards.

Responsibilities

• Lead the transfer of contract packaging processes to Ridgeville, SC.
• Author and implement SOPs and validation documentation.
• Act as technical project lead for new customer programs.

Skills

Mechanical Engineering

Manufacturing Engineering

Validation (IQ/OQ/PQ)

SOP Development

ISO 13485

cGMP

Project Management

Lean

Six Sigma

Education

Bachelor’s degree in Mechanical, Manufacturing, Industrial, or Packaging Engineering

Job description

Department: Industry - City, Country: Ridgeville, United States

With 1,700 employees and 14 factories across 3 continents, STERIMED is the world's leading manufacturer of materials and packaging systems for the sterilization of medical devices. Sterimed develops, produces, converts, and markets various solutions such as bacterial barrier substrates and preformed sterilization packaging, serving both hospitals and medical device manufacturers.

All the entities within the group work together in synergy to deliver reliable and innovative solutions, while the main site in France concentrates the industrial expertise and serves as the group’s innovation center.

With a strong entrepreneurial DNA, Sterimed has experienced rapid growth since its creation in 2016 through both organic development and external expansion: the size of the group has been multiplied by 5, and 10 acquisitions have been completed since 2017.

About the Role

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.
• 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.

STERIMED is committed to creating an inclusive and accessible working environment. Please feel free to inform us of any adjustment you may need to take part in the recruitment process.