Sr. Mechanical Engineer

Provides technical leadership in sustaining products for design, verification, investigation, reliability improvement of complex Class II and Class III medical devices, including Ventricular Assist Devices (VADs), extracorporeal blood pumps, oxygenators, and associated electromechanical systems. This individual serves as a subject matter expert responsible for leading complex technical investigations, driving product improvements, influencing engineering strategy, and solving challenging system-level problems throughout the product lifecycle. The role requires extensive collaboration across R&D, Quality, Regulatory, Manufacturing, Operations, and Supplier teams to ensure product safety, reliability, compliance, and performance.

Responsibilities:

• Provide technical leadership across multiple sustaining engineering initiatives involving Class II and Class III medical devices.
• Lead complex technical investigations associated with product performance, complaints, CAPAs, nonconformances, and field issues using structured root cause analysis methodologies.
• Research, develop, test, and sustain mechanical and electromechanical systems used in ventricular assist devices, extracorporeal blood pumps, oxygenators, and related cardiovascular products.
• Drive cross-functional efforts to identify, assess, and implement product, process, and reliability improvements throughout the product lifecycle
• Apply experimental, analytical, empirical, and numerical methods to evaluate product performance, investigate failures, and support engineering decisions.
• Develop test strategies, test methods, and protocols to evaluate system, subsystem, and component performance against product requirements.
• Design, develop, qualify, and validate equipment and fixtures used for engineering verification, reliability testing, and failure analysis activities.
• Identify technical risks and drive mitigation strategies throughout product development and sustaining activities.
• Analyze complaint, post-market surveillance, manufacturing, and reliability data to identify trends and drive continuous improvement initiatives.
• Create and review engineering drawings and specifications to ensure appropriate dimensioning, tolerancing, manufacturability, and assembly requirements.
• Perform and review tolerance analyses and engineering stack-ups to assess product robustness and manufacturability.
• Provide expertise in GD&T and mechanical system design principles.
• Support design reviews and provide technical guidance to engineers across multiple disciplines.
• Mentor and develop engineers through technical coaching, design reviews, and problem-solving activities.
• Evaluate manufacturing processes including precision machining, injection molding, silicone molding, extrusion, laser welding, ultrasonic welding, bonding, and mechanical assembly methods.
• Support supplier selection, qualification, and technical evaluations, including assessments of manufacturing capability, capacity, process controls, and quality systems.
• Collaborate with regulatory, quality, and clinical teams to support submissions, audits, inspections, and responses to regulatory inquiries.
• Ensure compliance with FDA regulations, international standards, company procedures, Quality Management System requirements, and applicable regulatory requirements.
• Support company initiatives as directed by management and contribute to continuous improvement of engineering processes, product quality, and operational excellence.

Qualifications:

• Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Manufacturing Engineering, or related engineering discipline.
• 10+ years of progressively increasing engineering responsibility supporting Class II and/or Class III medical devices, including product development, sustaining engineering, verification and validation, manufacturing support, and risk management activities.
• Expertise in mechanical design, tolerance analysis, GD&T, materials, manufacturing processes, and assembly methods.
• Demonstrated technical leadership of complex cross-functional programs and ability to influence technical decisions without direct authority.
• Strong understanding of FDA Design Controls, 21 CFR Part 820, product lifecycle management, and medical device development processes.
• Experience leading complex technical investigations and root cause analyses.
• Experience with risk management principles and methodologies, including FMEA analysis.
• Strong written, verbal, presentation, and technical communication skills.

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