Process Engineer, Packaging

ABOUT ORGANOX:

OrganOx is a commercial stage organ technology company dedicated to developing technologies to improve outcomes for patients with acute or chronic organ failure.

The company was established as a spin out of the University of Oxford in 2008 and is now part of the Terumo Group.

OrganOx is a pioneer in normothermic machine perfusion (NMP).

Its flagship platform, the metra®, is available for use in the U.S., Europe, Canada, and Australia.

It has been utilized in over 7,000 liver transplants to date to keep donor livers in a metabolically active state outside the body enabling longer preservation times and functional assessment of the organ prior to transplant, leading to an increased number of organs available for transplant.

Founded in 1921, Terumo Corporation (TSE:

Position Summary

The Process Engineer, Packaging is responsible for designing, developing, and validating packaging solutions for new and existing medical device products.

They will ensure that all packaging systems meet regulatory requirements, maintain product integrity, and support efficient manufacturing and distribution processes.

Working closely with cross-functional teams-including Quality, Regulatory, R&D, and Manufacturing-as well as external suppliers and contract manufacturing organisations (CMOs), this individual will play a critical role in ensuring packaging compliance, sustainability, and cost-effectiveness.

This position is essential to supporting the company's strategic goals for product quality, patient safety, and operational excellence.

The Process Engineer, Packaging will primarily work at OrganOx's Oxford site, with occasional travel to supplier & CDMO sites, and some opportunity to work from home as appropriate.

Major Responsibilities

Designing and developing packaging solutions for medical devices, ensuring compliance with ISO 11607 and other relevant standards

Leading packaging validation activities, including writing and executing protocols (IQ/OQ/PQ) for packaging processes and equipment

Collaborating with R&D and Manufacturing to ensure packaging designs meet functional, regulatory, and cost requirements

Creating and maintaining packaging specifications, drawings, and bills of materials

Performing transit and distribution testing (ISTA, ASTM) to ensure packaging integrity throughout the supply chain

Supporting sustainability initiatives by evaluating and implementing eco-friendly packaging materials and processes

Conducting risk assessments (e.g., FMEA) for packaging-related processes and implementing mitigation strategies

Ensuring packaging documentation is audit‑ready and compliant with GMP and ISO 13485 requirements

Working with suppliers and CMOs to qualify packaging components and processes

Participating in cross‑functional meetings to provide packaging updates, timelines, and risk assessments

Driving continuous improvement in packaging design, validation, and documentation practices

Adhere to the letter and spirit of OrganOx's Code of Conduct and all other company policies

Skills & Experience

Demonstrable experience in packaging engineering within the medical device, pharmaceutical, or biotech industry

Strong knowledge of packaging engineering principles and materials science

Experience in medical device packaging or other regulated industries (e.g., pharma, biotech)

Familiarity with ISO 11607, ISO 13485, FDA 21 CFR Part 820, and other relevant regulatory standards

Experience with packaging validation and distribution testing (ISTA, ASTM)

Knowledge of CAD software and packaging design tools

Proficiency in writing and reviewing technical documentation, including protocols, reports, and SOPs

Experience with risk management tools such as FMEA and control plans

Ability to manage multiple packaging projects simultaneously in a fast‑paced environment

Strong communication and interpersonal skills for effective collaboration with internal and external stakeholders

Detail-oriented with a commitment to quality, compliance, and continuous improvement

Qualifications

A degree/equivalent qualification in packaging engineering, materials science, mechanical engineering, or a related discipline (essential)

Certification in Lean, Six Sigma, or packaging-related training (desirable)

Benefits

At OrganOx, we value innovation, evidence, integrity, teamwork, respect, and passion.

We offer competitive compensation and comprehensive benefits, including healthcare and retirement plans.

We support work‑life balance and provide opportunities for ongoing professional development.

We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to age, disability, gender reassignment, marriage and civil partnership, p