Product Engineer

OrganOx, Inc.; Madison (NJ); Presencial; USD 90 000 - 120 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Health insurance

Dental insurance

Vision care

Disability coverage

401(k) retirement plan with company匹配

Paid time off

Holidays

Resumo da oferta

OrganOx, Inc. is expanding its Product Engineering team and seeking a Product Engineer to contribute to our existing product range.

You will support design changes, resolve manufacturing issues, and collaborate with Operations, Quality, and Development teams to transfer designs to production. The role requires experience with electro-mechanical devices, ability to design experiments, and strong technical reporting in English.

Qualificações

• Essential: Bachelor's degree in a relevant field; 5-7 years of experience in a similar role.
• Experience with electro-mechanical devices and designing/testing experimental plans.
• Ability to produce high-quality technical reports in English and manage multiple projects.

Responsabilidades

• Contribute to design changes to support product, production, and quality improvements; perform root cause analysis.
• Investigate device performance issues with quality, service and operations teams; propose corrective actions.
• Interpret product intended use and customer needs; generate and refine engineering documentation (DHF, DMR).
• Follow R&D procedures, failure analysis, design controls, and risk management per ISO 13485 and SOPs.
• Assist prototyping, bench tests, and transfer of designs to production.

Conhecimentos

Product engineering

Electro-mechanical devices

Design of experiments

Technical reporting

Multi-disciplinary teamwork

Supplier collaboration

Project management

Formação académica

Bachelor's degree in Computer Science, Software Engineering, Biomedical Engineering

Descrição da oferta de emprego

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

OrganOx is in the process of expanding its engineering capability and is seeking an enthusiastic Product Engineer to join the Product Engineering team.

As part of a small multi-disciplinary Product Engineering team, the successful candidate will have responsibility for activities focused on the existing product range in the following areas;

• Support the implementation and verification of design changes on the existing product range, to introduce new features and functionality and drive continuous improvement
• Work closely with the operations team in resolving component obsolescence, manufacturing issues, or complaints on the existing OrganOx product. This will require close partnership with field-based Customer service, Operations, and Quality teams
• Supporting the creation of assembly and test instructions required by the Operations team and suppliers, to ensure the transfer of designs to production are delivered in accordance with design change and operational SOPs
• Working closely with Product Development and Innovations teams throughout development projects with a focus on supporting design reviews and design transfer activities

Major Responsibilities

• Contributing to design changes to support product, production and quality improvements. This includes conducting problem-solving efforts and root cause analysis
• Investigating device performance issues, determining, and reporting the root cause (in collaboration with the quality, service and operations departments), and recommending corrective actions
• Interpreting and understanding the product's intended use, clinical procedures, customer needs and design inputs
• Creating and/or refining engineering documentation, such as the Design History File and the Device Master Record
• Following, learning, and contributing to R&D procedures, such as failure analysis, design controls and risk management, per the Quality Management System
• Assisting prototyping efforts and bench testing
• Prepare reports and conclusions for presentation
• Ensuring compliance with design and development procedures and ensuring all associated documentation is complete in accordance with ISO 13485 and local procedures

Skills and Experience

• Demonstrable experience within Product Engineering/Product Development, preferably within medical devices or another highly regulated industry
• Experience with electro-mechanical devices, with understanding of how to drive, interface with and troubleshoot devices
• Ability to design, implement and carry out experimental test plans for electro-mechanical, fluid components, sub-systems, and complete safety-critical systems
• Ability to produce technical reports to a high standard both in terms of technical content, presentation, and written English
• Enthusiasm, good communication skills and ability to work effectively in a multi-disciplinary team
• Ability to work effectively with outside suppliers and manufacturers
• Ability to work across and manage a range of projects or tasks simultaneously

Qualifications

Essential:

• Bachelors degree or equivalent qualification/experience in Computer Science, Software Engineering, Biomedical Engineering, or other relevant disciplines
• 5-7 years of experience of working in a similar role

A job description does not imply that the duties stated are the only ones to be performed by the job holder. Postholders 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.

• health
• dental
• vision
• disability coverage
• flexible spending accounts
• 401(k)-retirement plan with company matching after 90 days
• paid time off
• holidays
• additional leave benefits
• employee discounts
• access to our onsite wellness facility
• work-life balance and provides opportunities for ongoing professional development