Senior Mechanical Engineer

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.

• 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 Syn Cardia 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 Syn Cardia 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.

• Solid Works 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.

• 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.