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Associate Product Engineering Specialist

2 months ago


Madison, New Jersey, United States OrganOx Full time

OrganOx is at the forefront of revolutionizing organ transplantation since its inception, utilizing cutting-edge normothermic machine perfusion technology in our premier product, the OrganOx metra. This innovative technology aids in preserving donor livers for extended periods, thereby aiming to decrease organ discard rates and enhance transplant success rates. As a dynamic and rapidly growing global medical device organization, we are dedicated to advancing transplantation outcomes. We are currently seeking a proactive Junior Product Engineer to become a vital part of our team.

Position Overview

Reporting to the Senior Product Engineers, the Junior Product Engineer will play a crucial role in supporting the comprehensive life cycle of the metra. This encompasses aiding in field performance management, facilitating supplier and manufacturing enhancements, and contributing to feature upgrades. The role will involve collaboration with other Product Engineering team members across various locations.

Key Responsibilities

Under the guidance of the Senior Product Engineers and as part of a cohesive multi-disciplinary Product Engineering team, the Junior Product Engineer will be tasked with:

  • Assisting in investigations to identify the root causes of product failures.
  • Building strong partnerships with customer service, operations, and quality assurance teams.
  • Supporting the creation of assembly documentation and outputs required by the Operations team to ensure seamless design transitions to production.
  • Collaborating with New Product Development and Operations teams during project phases, focusing on design reviews and transfer activities.
  • Gaining a comprehensive understanding of the product's intended applications, clinical procedures, customer requirements, and design specifications.
  • Contributing to the development and refinement of engineering documentation.
  • Participating in R&D processes, including failure analysis, design controls, and risk management, in accordance with the Quality Management System.
  • Assisting in prototyping and bench testing activities.
  • Helping prepare visual presentations and findings for senior management review.
  • Exhibiting a strong sense of ownership, integrity, and commitment to excellence in all engineering tasks.
  • Adhering to OrganOx's Code of Conduct and all relevant company policies.

Required Qualifications

  • Bachelor's degree in mechanical engineering or a related field.
  • 0-5 years of relevant work experience.
  • Familiarity with mechanical engineering principles and design practices.
  • Proficiency in design and concept generation, along with engineering analysis using CAD and CAE tools.
  • Understanding of materials and manufacturing processes.

Preferred Experience

  • Experience in the medical device sector.
  • Prior exposure to medical devices under ISO 13485 Quality Management System.
  • Experience in supplier management.

This job description is not exhaustive and may include additional responsibilities as assigned by management.

What We Offer:

At OrganOx, we prioritize innovation, integrity, teamwork, respect, and passion. We provide competitive compensation and a comprehensive benefits package, including healthcare and retirement plans. We are committed to fostering work-life balance and offer opportunities for continuous professional growth.

We are an equal opportunity employer, and all qualified candidates will be considered 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.