Mechanical Manufacturing Engineer Jobs

ABOUT THE COMPANY

Paragonix Technologies is a leading developer, manufacturer, and service provider in the organ transplant industry, establishing a novel approach to preservation that represents a significant improvement over the traditional standard of care. Paragonix Advanced Organ Preservation devices combine clinically-proven, stable cooling techniques with digital tracking and monitoring technologies to provide clinicians complete control and oversight throughout the donor organ journey. The clinical impact of Paragonix preservation technology is reinforced by the GUARDIAN clinical registries, the largest database of organ preservation data in the world that analyzes post-transplant outcomes in transplant recipients.

Currently, Paragonix offers three FDA-cleared and CE-marked preservation devices: the Paragonix SherpaPak® Cardiac Transport System, the LUNGguard™ Donor Lung Preservation System, and the LIVERguard™ Donor Liver Preservation System. Transplant centers that utilize Paragonix devices have access to a comprehensive, 24/7 national support system composed of experienced transplant clinicians.

ABOUT THE ROLE

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

• Design test fixtures for product qualification using CAD and/or other technologies.
• 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.
• Develop/execute engineering project plans to reduce product risks and optimize resource utilization, including tooling qualifications, dual-sourcing projects, and continuous improvement cost reductions.
• Review documents and engineering change orders and maintain documentation control prior to release.
• Support root cause analysis for product failures, production challenges, and other issues as they arise.
• Travel overnight(s) as necessary both domestically and internationally to support project goals.
• 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.
• Design and set up feasibility tests to evaluate concepts, alternate materials, and changes within the production process.

REQUIRED QUALIFICATIONS

• Bachelor’s degree in Mechanical Engineering or applicable engineering discipline required.
• Experience with GD&T Tolerancing Guidelines and engineering drawing generation.
• 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.
• Proficiency in SolidWorks
• Demonstrate excellent project team skills as part of a cross-functional team that includes development/procurement/manufacturing/regulatory/quality.
• Experience with organized root cause analysis (5 Whys, Ishikawa, etc.) techniques
• Demonstrated experience and ability to work autonomously with SolidWorks computer aided design
• 0 - 2 years of manufacturing engineering experience within the medical device/technology industry.

PREFERRED QUALIFICATIONS

• Six Sigma certification
• 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 leading engineering projects utilizing Lean Manufacturing concepts.
• Experience with risk management tools including System Hazard Analysis (SHA) and Failure Mode and Effect Analysis (FMEA)

OTHER REQUIREMENTS

• This role is an on-site position (post-pandemic)
• Must be willing to travel domestic and/or internationally approximately 20% of the time

Paragonix Technologies is committed to equality and affirms the right of every qualified applicant to receive consideration for employment without regard to race, color, religion, sex, gender identity or expression, national origin, sexual orientation, genetic information, disability, age, ancestry, military service, protected veteran status.