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 cold preservation techniques in a novel suspension system to provide unprecedented physical and thermal protection. Paragonix SherpaPak™ CTS is the only commercially available FDA cleared and CE marked transport device for heart transportation. Paragonix is also developing transport devices for the lung and kidneys designed to improve donor organ quality and extending donor organ transport time.
Reporting to the Manufacturing organization, this position is a critical member of the manufacturing and supply chain operations team. This role is responsible for product lifecycle management including failure analysis and maintenance of CAD 3D models, semi-autonomous project management related to existing products in the market, and resolving bottlenecks to capacity and supply. The successful candidate will focus efforts on sustaining and implementing breakthrough improvements to our market products and developing Paragonix’s contract manufacturing supply chain.
Primary responsibilities will include:
- Support root cause analysis for product failures, production challenges, and other issues as they arise.
- Maintain, edit, and publish CAD (SolidWorks) updates as necessary to existing products. This will include routine drawing updates and new design iterations to improve quality, service, and cost.
- Develop/execute engineering project plans to reduce product risks and optimize resource utilization, including tooling qualifications, dual-sourcing projects, and continuous improvement cost reductions.
- Design and set up feasibility tests to evaluate concepts, alternate materials, and changes within the production process.
- Review documents and engineering change orders and maintain documentation control prior to release.
- Design test fixtures for product qualification using CAD and/or other technologies.
- Travel overnight(s) as necessary both domestically and internationally to support project goals.
- Support/lead cross functional teams as a mechanical engineering and/or supply chain representative depending on the project scope. Liaison cross-functionally with stakeholders to drive alignment with project goals.
- Bachelor’s degree in Mechanical Engineering or applicable engineering discipline required.
- 0 – 2 years of manufacturing engineering experience within the medical device/technology industry.
- Working knowledge of medical device regulations (ISO 13485, ISO 14971, 21 CFR part 820) and statistical analysis, OR a strong motivation and ability to quickly “learn as you go” from experienced teammates.
- Demonstrated experience and ability to work autonomously with SolidWorks computer aided design
- Experience with organized root cause analysis (5 Whys, Ishikawa, etc.) techniques
- Demonstrate excellent project team skills as part of a cross-functional team that includes development/procurement/manufacturing/regulatory/quality.
- Ability to present a portfolio of work (business or academic) examples related to drafting, surfacing, and complex design tasks.
- Experience with component design and material selection as it relates to Design for Manufacturing (DFM)
- Experience with risk management tools including System Hazard Analysis (SHA) and Failure Mode and Effect Analysis (FMEA)
- Experience leading engineering projects utilizing Lean Manufacturing concepts.
- Six Sigma certification
- This role is an on-site position (post-pandemic)
- Must be willing to travel domestic and/or internationally approximately 20% of the time