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Lungpacer Medical USA, Inc. is developing a novel therapeutic solution for preserving the integrity and strength of the diaphragm muscle in critically ill patients who require mechanical ventilation and is seeking to hire an experienced and highly motivated Senior Mechanical Engineer to be based at our Exton, PA location.

As a member of the Mechanical Engineering Team, the position is responsible for providing design and technical expertise in area of assigned development activities, primarily related to Catheter development. Other responsibilities as requested.

Responsibilities

• Demonstrate knowledge of engineering principles and its application in solving complex problems.
• Demonstrate working knowledge of product enhancements and manufacturing process refinement.
• Use analysis tools and methods to solve complex technical problems (e.g. CAD, FEA. CFD).
• Demonstrate strong knowledge of materials and processes related to catheter design and manufacturing.
• Generate catheter design concepts and prototypes using specialized hand tools to test their mechanical and electrical properties.
• Assist in the transfer of R&D prototypes builds to manufacturing by developing repeatable and accurate processes.
• Develop and assist in the design of fixtures and tooling used in fabrication and testing of catheter prototypes.
• Support manufacturing activities as needed.
• Generate CAD models and technical drawing files for fabrication in accordance with company drafting standards as applicable.
• Develop design verification test methods and test fixtures to verify catheter functional requirements.
• Lead individual design verification test methods, including writing test protocols, overseeing test progress, providing direct input in test activities and preparing test reports at completion.
• Pre-clinical testing, data collection and analysis of prototype catheters.
• Support activities to enhance IP portfolio of the company.
• Collaborate with outside vendors to obtain quotes, technical information, and purchase materials/supplies and equipment/tooling.
• Technical writing and presentations.
• Create and oversee the preparation of mechanical engineering designs, drawings, specifications, schedules, and cost estimates.
• Provide technical assistance to other mechanical engineers and resolve technical issues.
• Create validation documentation (IQ, OQ & PQ) and lead the execution of process qualifications for new and existing processes.

Qualifications

• Bachelor’s in Mechanical/Biomedical Engineering or related field.
• 8+ years of medical device industry or related experience OR Master’s Degree in Engineering and 6+ years related experience.
• Demonstrated SolidWorks experience or other CAD software tools.
• Excellent organizational, analytical reasoning, problem-solving, and conflict management skills.
• Ability to successfully navigate complex environments and relationships.
• Excellent interpersonal and communication (both oral and written) skills.
• Skilled in the use of word processing, database, spreadsheet, image editing, and desktop publishing software, as well as web searching techniques.
• Ability to handle confidential and sensitive material with discretion.
• Knowledge of medical device regulations and standards.

Additional Notes:

• This role is expected to work independently and with minimal supervision, under the direction and support of management.
• This role may involve supervision and management of Interns and other junior staff.
• Regular office work and R&D Lab environment. PPE and/or cleanroom gowning may be required, if entering the laboratories and/or cleanroom.