Director, Product Engineering

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). It's 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:4543) strives to fulfill its mission of “Contributing to Society through Healthcare” by providing a comprehensive range of solutions in the fields of therapeutic procedures, hospital operations, and life sciences in more than 160 countries and regions.

Position Summary

The Engineering Director – Product Engineering position oversees project management and addresses supply and design-related matters for the released portfolio of OrganOx Normothermic Machine Perfusion (NMP) products, currently the ‘metra’. The metra device is a medical system integrating multiple engineering disciplines, utilizing both capital equipment and disposable components to support liver transplants and improve organ availability.

Responsibilities include developing new features within the lifecycle management of the current product range. This role involves leading cross-functional teams to identify issues, develop corrective action plans, and implement solutions related to both technical product matters and broader product development challenges. This position requires interaction with upper management for project reporting and phase reviews. The role encompasses experience with various therapies, products, and operational considerations connected to patient care and business objectives.

This is a full-time role in Madison, NJ, with extensive collaboration with colleagues based in Oxford, UK.

Major Responsibilities

As the leader of a small multi-disciplinary Product Engineering team, and under the direction of the SVP, Product Engineering, the successful incumbent will drive activities in the following areas:

• Lead cross-functional team members to ensure clear communication and coordination of project/program objectives, deliverables, and timing of key milestones.

• Orient quickly to understand new quality issues based on field or factory performance, and to concurrently manage multiple projects with different teams and while balancing competing priorities.

• May take direct responsibility for design-related CAPAs (Corrective and Preventive Action) within the Product Engineering department as well as process focused CAPAs.

• Author investigation (i.e., root cause analysis) plans, reports, and supporting documents of high quality (i.e., submission and audit/inspection ready) that are technically sounds, critically reasoned, and use appropriate root cause tools/methodologies (e.g., 5-Whys/Cause Map, Contradiction Matrix, other DRM/Six Sigma problem-solving and statistical analyses).

• Provide clear and concise communication – both written and verbal. Author strong documentation with attention-to-detail that is audit-ready. Present team’s investigation findings and action recommendations to quality (e.g., CAPA Board) and other management/business stakeholders.

• Plan schedule and resources (e.g., labor skills sets and duration, expenses) to achieve desired project outcomes.

• Responsible for maintaining a focus on quality, while effectively partnering with Quality, R&D, Operations, and Regulatory stakeholders to facilitate consensus, resolve disagreements, and ensure sound decision-making.

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

Requirements:
Skills & Experience

• Experience in medical device or highly regulated industry.

• Experience or technical education in software development, software or computer engineering, and/or software quality assurance, including knowledge of IEC 62304 (Medical device software – software life cycle processes).

• Experience with medical device systems that include software applications and/or embedded software (i.e., firmware).

• Experience leading a complex project/program including cross functional team leadership, risk-based decision making, financial accountability, and ability to manage change implementation.

• Background with CAPA (Corrective and Preventive Action) process, and/or experience with the use of root cause investigation, problem-solving, or similar structured methodologies and tools (e.g., 5-Whys, Fishbone, etc.)

• Experience participating in or supporting audits or external inspections (e.g., FDA, TUV, internal audit).

• Proven experience in achieving results through influence management and motivating teams.

• Knowledge and/or experience with product development processes and/or QMS (Quality Management System) Design Control procedures.

• Strong understanding of global regulatory requirements for medical devices, including FDA regulations (e.g., 21CFR Part 820), ISO 13485, Medical Device Directive, and European Medical Device Regulation.

• Working knowledge of Project Management methodologies and tools, including Project Management Professional (PMP) trained or certified

Qualifications

• Requires a bachelor’s degree in engineering and minimum of 5 years of relevant experience, or advanced degree with a minimum of 3 years of relevant experience.

• Certified practitioner in Design for Reliability and Manufacturability (DRM), Design for Six Sigma (DFSS), or Lean Sigma methodologies.

• Ability to travel 15%

A job description does not imply that the duties stated are the only ones to be performed by the job holder. Job holder will be required to follow any other job-related instruction as reasonably requested by their line manager or their designate.

Benefits:
We offer competitive compensation and comprehensive benefits available from day one, including health, dental, vision, disability coverage, and flexible spending accounts. Additionally, we offer a 401(k)-retirement plan with company matching after 90 days, paid time off, holidays, and additional leave benefits, as well as employee discounts and access to our onsite wellness facility. OrganOx supports work-life balance and provides opportunities for ongoing professional development.

We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity or expression, national origin, disability status, protected veteran status, genetic information, or any other characteristic protected by law.