Senior Mechanical Engineer NxGen

DESCRIPTION

TransMedics, Inc., headquartered in Andover, MA, is revolutionizing organ care. With the goal of bringing new life to organ transplant, the pioneering Organ Care System (OCS™) was developed to address the major limitations of the current standard of care, cold storage. The OCS System serves as a portable, miniature intensive care unit that helps preserve donor organs in a near-physiologic state during transport. Unlike traditional cold-storage methods, the OCS System features ex-vivo, warm perfusion, and provides the means to monitor organ health, so that transplant patients can experience better outcomes. The only multi-organ platform, with the largest body of clinical evidence, the OCS System is designed to increase utilization and transplant volumes so that more transplantable organs can be made available worldwide. The Organ Care System is nothing less than a paradigm shift that can help transform organ preservation and optimization so that more patients can benefit from life-saving transplant procedures.

TransMedics is developing the Next Generation Organ Care System and is looking for an exceptional mechanical engineer with a proven track record of delivering innovative solutions to the disposable medical device market. This role is heavily focused on developing the next generation disposable for the Organ Care System. A strong technical background and expertise in injection molding and SolidWorks are required. The ideal candidate will be extremely creative, highly motivated and has brought complex medical disposables from concept to commercialization.

ESSENTIAL JOB RESPONSIBILITIES AND DUTIES INCLUDE:

• Responsible for working with internal and external mechanical and industrial design teams to develop the next generation disposable for the OCS Heart, OCS Lung and OCS Liver product lines.
• Must be a creative problem solver that can think outside of the box to develop novel solutions to complex medical device problems
• Responsible for designing and rapid prototyping new concepts and iterating through the design process
• Expert in injection molding and plastics to ensure designs are manufacturable and biocompatible.
• Perform fluid flow analysis on new designs and analyze the impact on red blood cells
• Perform injection mold validations and first article inspection protocols and reports
• Develop drawings in accordance with applicable standards
• Collaborate with outside suppliers on the sourcing of materials and components
• Prepare documentation to support quality system for design functions (project plans, design input, risk assessment, test protocols and reports, drawing specifications, etc.)
• Work closely with manufacturing engineering to ensure designs are capable of being assembled and tested using advanced manufacturing automation
• Collaborate and communicate with cross-functional teams and leadership
• Build and test engineering prototypes using laboratory equipment and document in DHF

REQUIREMENTS

• At least 7 years of experience performing mechanical engineering with 3 years in a lead role for complex capital equipment and disposable medical device products.
• Expert in Solidworks 3D modeling and design of injection molded, machined, and sheet metal components
• Ability to work independently with high competency and little guidance
• Solid foundation of mechanical engineering fundamentals and ability to perform detailed engineering analysis including tolerance analysis, FEA, engineering 1st principle
• Strong knowledge of rapid prototyping techniques and materials for disposable medical devices
• Must be able to work in a fast paced, high energy, collaborative team that possesses a strong sense of urgency
• Strong written and verbal communication skills are required
• Strong understanding of medical device development processes including experience with FDA CFR 820 and ISO 13485 regulations
• Strong hands-on skills and ability to use power tools and light machine shop equipment
• Previous experience with biocompatibility and sterility testing is strongly preferred
• Previous experience working on Class II or III medical device is strongly preferred
• Previous experience developing blood contacting disposables is strongly desired
• Six Sigma Green Belt is strongly desired.

EDUCATION:

• BS in Mechanical Engineering, Plastics Engineering, Biomedical Engineering, or equivalent is required
• Advanced degree strongly preferred