Product Development Engineer bei Paragonix Technologies, Inc

Paragonix Technologies markets organ transportation devices that safeguard organs during the journey between donor and recipient patients. Our devices incorporate clinically proven and medically trusted hypothermic preservation techniques in a novel suspension system to provide unprecedented physical and thermal protection. Our product portfolio spans cardiac, thoracic, and abdominal preservation devices to improve donor organ quality and extend donor organ transport time.  Paragonix also markets transplant services and organ screening to the transplant community. 

Our company provides the leading commercial system for heart preservation and transportation as well as transplant systems for kidney, lung, liver and pancreas. As we grow, we are looking to add a Product Development Engineer to our team.  Reporting to management level in R&D, this position is a critical member of the Product Development team focused on both developing new products and features as well as interfacing Manufacturing to ensure products can be realized effectively and efficiently. In this role you will use your technical expertise through innovation, design, development, verification, validation, and launch of electro-mechanical systems.

Primary responsibilities will include:

• Lead the development of new products and product features from concept through manufacturing transfer in partnership with marketing, program management, operations, and quality team-members.
• Prototype generation and Verification and Validation testing ownership, including test protocol and test report authorship (design verification and design validation).
• Own relationships with component and assembly suppliers to facilitate qualification of new parts, tools and assemblies during the product development process.
• Oversee development of manufacturing procedures, processes, tooling, and fixtures to satisfy product demand and quality requirements.
• Provide production line support including implementing process improvements, troubleshooting equipment, and addressing product issues in partnership with operations and quality teams.
• Write and execute process and equipment validations (IQ/OQ/PQ/MVP/TMV), as well as associated risk management activities (DFMEA/PFMEA/Risk Assessment) and 3D CAD files with associated component prints.
• Lead on-going product and process improvement through design and process modifications in response to end user-derived inputs and feedback

Qualifications:

• Demonstrated ability to lead advancement of a product through concept process to manufacture transfer
• Strong communication, collaboration, problem solving, and critical-thinking skills
• 4+ years of medical device development experience, primarily related to Good Lab Practices, design control and risk documentation generation
• Self-motivation with a passion for solving complex problems
• Proficiency in Solidworks strongly preferred
• Bachelor’s degree in an applicable engineering discipline required
• Advanced degree in an applicable engineering discipline preferred

General responsibilities:

• Ability to work in office a minimum of 4 days per week.
• Must be willing to travel 10%-25%