Senior Mechanical Product Engineer

ABOUT ORGANOX:

OrganOx is an innovative, fast-paced, global medical device company with a mission to save lives by making every donated organ count. We are a commercial stage organ technology company, spun out of the University of Oxford in 2008, committed to improving transplantation outcomes throughout the world. The company’s first product, the OrganOx metra® normothermic machine perfusion (NMP) system for liver transplantation, has been used to support more than 5,000 liver transplant operations globally.

Position Summary

As part of a small multi-disciplinary Product Engineering team, Senior Mechanical Engineer will support design activities in the following areas:

·       Identifying, implementing, and verifying design changes relating to product enhancements, component obsolescence and complaints resolutions on the existing OrganOx product range.

·       Supporting the creation of assembly instructions and outputs required by the Operations team, to ensure the transfer of designs to production are delivered in accordance with design change and operational SOPs.

·       Working closely with the New Product Development and Operations teams throughout development projects with a focus on supporting design reviews and design transfer activities.

·       Serve as the functional lead within the Mechanical Engineering discipline focused on consumable systems for the current generation of perfusion technology

The candidate’s experience should include risk management, change control, tolerance analysis, DFMA and the development of test methods and protocols.

The candidate will create, control, and maintain detailed CAD assemblies, parts, and drawings, therefore experience in SOLIDWORKS and PDM is essential. Previous experience in medical devices under ISO 13485 QMS is also advantageous.

The OrganOx device consists of a transportable active device and a single-use sterile, disposable set. Both systems utilize a number of components from external suppliers and the role will require collaboration with suppliers to ensure that design requirements are well specified and that designs meet specification.

The candidate requires excellent written and verbal communication skills to document their activities in line with the ISO13485 Quality Management System, planning and reporting on their work to a standard suitable for review by project stakeholders and regulatory authorities.

This is a full time, in office role located at OrganOx’s US headquarters in Madison, NJ.

Major Responsibilities

Responsible for the aspects of mechanical design on the OrganOx product and sub-systems.

·       Ensure all design changes are carried out in accordance with design control and design change processes, whilst maintaining compliance with applicable standards.

·       Design, source and verify new components and assemblies.

·       Detail, release and maintain 2D and 3D mechanical parts, assemblies, and drawings in SolidWorks.

·       Perform device Risk Analysis/ FMEA activities.

·       Prototyping and assembly of parts to facilitate the test and validation process.

·       Develop test methodologies for verification/validation activities

·       Supporting root cause analysis and implement changes for complaints resolution Ensuring designs are robust, well-evaluated and capable of withstanding the lifetime requirements of transportable electromechanical devices.

·       Collaborate with the Operations team and contract manufacturing organizations to ensure assembly, and service requirements are considered throughout the design change process.

·       Input to design for manufacture and assembly reviews on new products.

·       Ensuring that CAD, drawings, and design outputs are effectively transferred to production for new product introductions.

Skills & Experience

·         Proven track record in the design and development of complex electro-mechanical devices, preferably within medical devices or another highly regulated industry.

·         Experience working within medical device development environment, specifically Design Change Controls and Design Verification compliant with ISO 13485, MDR, 21 CFR 820 and other relevant regulations. Other regulated environments will be considered.

·         Strong knowledge of mechanical engineering principles, materials science, and manufacturing processes

·         Awareness of medical device safety and compliance test standards such as ISO 60601-1

·         Ability to produce Technical Reports to a high standard both in terms of technical content, presentation, and written Engl