SynCardia Systems, LLC
Overview
Provide mechanical engineering and project leadership to support existing Total Artificial Heart System (THS) production, sustaining engineering, and research & development activities. Maintain product and company reputation by complying with government regulations, supporting quality systems, and ensuring engineering and documentation requirements are met.
Responsibilities
Provide mechanical engineering and project leadership to support existing THS production in sustaining engineering and manufacturing as required by business needs.
Support research and development activities for new THS products.
Answer engineering questions and requests, delivering clear information to internal stakeholders.
Maintain good documentation practices for all aspects of work.
Participate in related company projects to gain a solid working understanding of SynCardia business and quality systems.
Maintain professional and technical knowledge by attending workshops, reviewing publications, establishing networks, and participating in professional societies.
Evaluate mechanical, electromechanical, and pneumatic systems and products by designing and conducting research programs; applying principles of mechanics, thermodynamics, hydraulics, heat transfer, and materials.
Assist in sustaining engineering and improvement of existing THS products.
Assist in developing new products to support the THS portfolio.
Confirm system and product capabilities by designing feasibility and testing methods.
Create and revise product requirement specifications.
Develop and improve manufacturing processes by designing and modifying equipment for fabricating, building, assembling, and installing components.
Prepare product test and investigation reports by collecting, analyzing, and summarizing information.
Maintain system and product drawing database.
Contribute to engineering or company team assignments.
Research and champion regulatory requirements related to mechanical engineering for SynCardia products.
Actively participate in new product transfer into manufacturing, ensuring engineering and quality documentation requirements are achieved.
Provide mechanical engineering support for existing THS products in manufacturing and R&D, assisting with design and analysis to ensure product changes and improvements meet performance, schedule, and cost objectives.
Qualifications
SolidWorks CAD software (v2012 or later) – 3D modeling, detailed dimensioned drawings, and bills of materials.
Knowledge of pneumatic systems and mechanical measurement tools and techniques.
Experience designing plastic and metal parts, assemblies, and documentation.
Familiarity with geometric dimensioning and tolerancing per ASME Y14.5M.
Understanding of physical requirements analysis, mechanical concepts, and design.
Strong presentation and communication skills, both written and verbal.
Quality focus and attention to detail.
Excellent organizational skills and ability to handle multiple tasks simultaneously.
Team player and collaborative mindset with professional ethics.
Adaptability and quick learning in a dynamic environment.
Bachelor’s Degree in Mechanical Engineering and 10‑15 years of similar industry experience, or Master’s Degree in Engineering and 5‑10 years of similar industry experience.
MS in Mechanical, Electrical, or related engineering highly preferred.
Regulated device experience and familiarity with mechanical design philosophies, processes, tools, and standards.
Work Environment
Workstation Area: Office.
Special Factors: None.
Indoor environment, seasonally heated and cooled, minimal noise.
Requires sitting, typing, and moving objects less than 25 pounds.
Communication requires in‑person, telephone, and email interactions.
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Responsibilities
Provide mechanical engineering and project leadership to support existing THS production in sustaining engineering and manufacturing as required by business needs.
Support research and development activities for new THS products.
Answer engineering questions and requests, delivering clear information to internal stakeholders.
Maintain good documentation practices for all aspects of work.
Participate in related company projects to gain a solid working understanding of SynCardia business and quality systems.
Maintain professional and technical knowledge by attending workshops, reviewing publications, establishing networks, and participating in professional societies.
Evaluate mechanical, electromechanical, and pneumatic systems and products by designing and conducting research programs; applying principles of mechanics, thermodynamics, hydraulics, heat transfer, and materials.
Assist in sustaining engineering and improvement of existing THS products.
Assist in developing new products to support the THS portfolio.
Confirm system and product capabilities by designing feasibility and testing methods.
Create and revise product requirement specifications.
Develop and improve manufacturing processes by designing and modifying equipment for fabricating, building, assembling, and installing components.
Prepare product test and investigation reports by collecting, analyzing, and summarizing information.
Maintain system and product drawing database.
Contribute to engineering or company team assignments.
Research and champion regulatory requirements related to mechanical engineering for SynCardia products.
Actively participate in new product transfer into manufacturing, ensuring engineering and quality documentation requirements are achieved.
Provide mechanical engineering support for existing THS products in manufacturing and R&D, assisting with design and analysis to ensure product changes and improvements meet performance, schedule, and cost objectives.
Qualifications
SolidWorks CAD software (v2012 or later) – 3D modeling, detailed dimensioned drawings, and bills of materials.
Knowledge of pneumatic systems and mechanical measurement tools and techniques.
Experience designing plastic and metal parts, assemblies, and documentation.
Familiarity with geometric dimensioning and tolerancing per ASME Y14.5M.
Understanding of physical requirements analysis, mechanical concepts, and design.
Strong presentation and communication skills, both written and verbal.
Quality focus and attention to detail.
Excellent organizational skills and ability to handle multiple tasks simultaneously.
Team player and collaborative mindset with professional ethics.
Adaptability and quick learning in a dynamic environment.
Bachelor’s Degree in Mechanical Engineering and 10‑15 years of similar industry experience, or Master’s Degree in Engineering and 5‑10 years of similar industry experience.
MS in Mechanical, Electrical, or related engineering highly preferred.
Regulated device experience and familiarity with mechanical design philosophies, processes, tools, and standards.
Work Environment
Workstation Area: Office.
Special Factors: None.
Indoor environment, seasonally heated and cooled, minimal noise.
Requires sitting, typing, and moving objects less than 25 pounds.
Communication requires in‑person, telephone, and email interactions.
#J-18808-Ljbffr