Manufacturing Engineer, Consoles

Job Description

Job DescriptionThe Company
Our client is a fast-growing, venture-backed medical device company dedicated to transforming the diagnosis and treatment of coronary artery disease (CAD)—the world’s leading cause of death. Their groundbreaking intravascular imaging platform integrates advanced optical technologies, spectroscopy, and intelligent software to provide real-time, highly detailed insights that help physicians optimize coronary interventions.Following a recent Series B funding round led by a major strategic investor in healthcare innovation, our client is scaling rapidly and investing in technologies and talent that will reshape cardiovascular care. This is an exciting opportunity to join a tight-knit and mission-driven team that’s pushing the boundaries of innovation in a high-impact, fast-paced environment.Job SummaryIn this role, you will be responsible for developing and optimizing manufacturing processes for complex electro-mechanical medical devices and catheters, with a strong focus on design for manufacturability and production scalability. You will support the production team by creating and refining test methods, executing component and system-level testing, and planning and leading verification and validation (V&V) activities. You’ll work closely with cross-functional teams to implement efficient production workflows, generate clear work instructions, and ensure robust quality control. Using statistical analysis tools such as DOE, SPC, and Gage R&R, you will identify trends, drive process improvements, and perform root cause analysis as needed. Collaboration with R&D, Quality, and Regulatory teams will be key to maintaining compliance with medical device standards, including ISO 13485 and FDA QSR. Key Responsibilities

• Develop assembly processes in support of manufacturing and in conjunction with R&D departments.
• Design, build and qualify tooling and fixtures for low to high volume assembly.
• Identify areas for process improvement and implement new methods.
• Administer/monitor all processes related to the disposition of non-conforming material including but not limited to documenting non-conformance, performing root cause analysis, and drive corrective actions with internal or external stakeholders.
• Track, trend and analyze process output data using SPC principles.
• Author and execute protocols for process validation/qualification activities, including planning and executing validation plans, IQ/OQ/PQs, etc.
• Enhance quality system processes as it pertains to the resolution of issues arising from manufacturing operations as well as post-manufacturing activities, including driving continuous improvement throughout the quality system.
• Assist or leads CAPA evaluation and closure.
• Performs other duties as required.

Requirements

• 2-4 years of manufacturing experience in the medical device industry.
• Experience with fixture and tool design.
• Able to use measuring equipment such as calipers, micrometers, height gages, pin gages, etc.
• Knowledge of Geometric Dimensioning and Tolerancing (GD&T).
• Able to competently read and interpret mechanical drawings.
• Must be a self-starter and a fast learner, must work efficiently, both independently and within a team.
• Must have robust problem-solving skills and a high degree of attention to detail.
• Communication, organizational, and critical thinking skills.
• Ability to track and manage multiple projects and deadlines.
• Ability to travel, typically no more than 30% of the time.

Desired Qualifications

• Experience building, qualifying and testing electro-mechanical devices
• Experience with ERP systems such as SAP, NetSuite etc., is desirable.
• Experience in working with hazard analyses and risk analysis tools, such as PFMEA and FTA.
• Experience working with complex medical systems containing software, hardware, and disposable.
• Working knowledge of ISO13485, ISO 14971, IEC 62304, EU Medical Device Regulation, and FDA QSR requirements.