POSITION OVERVIEW

The Quality Engineer, Staff (Catheters) will Support the design, development, transfer, and commercialization of Class II and Class III interventional catheter systems. The Design Quality Engineer (DQE) will collaborate with a cross-functional team to support new product and process design and development activities from concept through transfer to commercialization. The DQE will ensure compliant product interface, integration, and performance in adherence to 21 CFR Part 820, ISO 13485, ISO 14971, ISO 62304, and IEC 60601.

EDUCATION, EXPERIENCE AND SKILLS REQUIRED

Below are the minimum skills, formal education, certifications or training, and practical experience required to perform the general functions and duties of the role.

• Bachelor’s degree or higher in Mechanical, Biomedical, or Materials Engineering.
• 5-9 years of experience in catheter development for medical devices.
• Extensive experience with R&D projects and the full product life cycle for medical devices.
• Strong problem-solving, analytical, and communication skills, with high attention to detail.
• Substantial knowledge of catheter processes and technologies, product design and development, and quality engineering/design quality engineering in medical devices.
• Demonstrated ability to work effectively with Design Process, Manufacturing, Regulatory, Quality, Research and Development, Systems, and Software teams.
• Experience in design control and risk management, including authorship of design control deliverables and ensuring compliance with regulatory standards across the product lifecycle.
• Hands-on experience with 21 CFR Part 820, ISO 13485, ISO 14971, ISO 62366, IEC 60601, and EU MDR.
• Extensive experience with design verification, validation, clinical studies, usability testing, human factors, and test validation.
• Strong understanding and application of Class II and Class III devices, product realization performance requirements, and General Safety and Performance Requirements (GSPR).
• Leadership experience with nonconforming material reports, investigations, failure mode analysis, corrective actions, and CAPA.
• Preferred Qualifications
• Experience working in medical device cleanrooms (Class 7 and/or 8) and performing cleanroom validations.
• Strong knowledge of printed circuit boards and/or integration of interventional catheters into medical device systems.
• Experience with catheter processes including tip forming, extrusion, laser bonding, and braid/coil reinforcements.
• Hands-on experience with IEC 60601 testing requirements and the certification process for medical electrical devices, equipment, and systems.
• Strong knowledge of interventional catheter interfaces, interactions, and compatibility with their respective electrical equipment systems.
• Hands-on experience with test method validation, root cause investigation, and analysis.
• Leadership experience in supplier qualification and approval, management of internal/external audits, and notified body audits.
• Six Sigma Black Belt certification, with experience applying Six Sigma methods such as DFSS, DMAIC, and DoE.
• Experience in Design for Manufacturing and Assembly (DFMA) and reviewing tolerance analysis.
• Experience with simulated use, in-process, and finished testing for both non-electrical and electrical medical devices.
• Experience with catheter-based technologies and processes, with understanding of system-level interactions and integrations, including electrical, mechanical, and human interface risks, mitigations, and considerations.

Our pay ranges are determined by role, level, and location. The range displayed on each job posting reflects the minimum and maximum new hire pay for the position located in California. Within the range, individual pay is determined by location, additional factors, including job-related skills, experience, and relevant education or training.
EnChannel Medical is an E-Verify and equal opportunity employer. We believe in hiring a diverse workforce and sustaining an inclusive, people-first culture. We are committed to non-discrimination on any protected basis, such as disability and veteran status, or any basis covered under acceptable law.
Only qualified candidates will be contacted

DUTIES AND RESPONSIBILITIES

The following are the major responsibilities needed for the role. Additional responsibilities, tasks, and duties will be assigned and required as needed.

• Represent Quality as an experienced expert for new projects, products, and processes.
• Ensure design controls for new projects meet applicable QMS, product, and regulatory requirements.
• Maintain knowledge and application of statistical analysis and software to support acceptance criteria for technical documentation.
• Collaborate in and support technical, design, and phase reviews.
• Support regulatory submissions with applicable technical documentation.
• Participate in internal, external, and notified body audits.
• Support new product and/or new process development, including:
• Creating and supporting Document Change Orders, Engineering Change Orders, IQs, OQs, PQs, project/test plans, protocols, and reports.
• Collaborating in the design, development, and release of product, process, and reliability requirements with specifications.
• Contributing to new product design and development plans, animal studies, clinical plans, protocols and reports, design verification and validation protocols and reports, and human factors/usability studies.
• Creating the risk management file, leading the risk management process, facilitating quality discussions for development and design, and ensuring completion of risk documentation.
• Developing, collaborating on, and supporting hazard analyses and FMEAs, implementing and assessing risk mitigations, and ensuring technical applicability.
• Providing technical guidance for design and process changes, leading impact assessment discussions, and ensuring applicable process/product testing with technical justification documentation.
• Authoring or supporting design control deliverables, including design verification, design validation, clinical studies, shelf life, packaging, biocompatibility, sterilization validation, usability, human factors, and cybersecurity.
• Leading the supplier approval process, interfacing with external suppliers, ensuring product quality, and leading internal and external audits.
• Managing the design history file and ensuring phase review deliverables are completed in accordance with QMS requirements.

Below are the minimum skills, formal education, certifications or training, and practical experience required to perform the general functions and duties of the role.

• Bachelor’s degree or higher in Mechanical, Biomedical, or Materials Engineering.
• 5-9 years of experience in catheter development for medical devices.
• Extensive experience with R&D projects and the full product life cycle for medical devices.
• Strong problem-solving, analytical, and communication skills, with high attention to detail.
• Substantial knowledge of catheter processes and technologies, product design and development, and quality engineering/design quality engineering in medical devices.
• Demonstrated ability to work effectively with Design Process, Manufacturing, Regulatory, Quality, Research and Development, Systems, and Software teams.
• Experience in design control and risk management, including authorship of design control deliverables and ensuring compliance with regulatory standards across the product lifecycle.
• Hands-on experience with 21 CFR Part 820, ISO 13485, ISO 14971, ISO 62366, IEC 60601, and EU MDR.
• Extensive experience with design verification, validation, clinical studies, usability testing, human factors, and test validation.
• Strong understanding and application of Class II and Class III devices, product realization performance requirements, and General Safety and Performance Requirements (GSPR).
• Leadership experience with nonconforming material reports, investigations, failure mode analysis, corrective actions, and CAPA.
• Preferred Qualifications
• Experience working in medical device cleanrooms (Class 7 and/or 8) and performing cleanroom validations.
• Strong knowledge of printed circuit boards and/or integration of interventional catheters into medical device systems.
• Experience with catheter processes including tip forming, extrusion, laser bonding, and braid/coil reinforcements.
• Hands-on experience with IEC 60601 testing requirements and the certification process for medical electrical devices, equipment, and systems.
• Strong knowledge of interventional catheter interfaces, interactions, and compatibility with their respective electrical equipment systems.
• Hands-on experience with test method validation, root cause investigation, and analysis.
• Leadership experience in supplier qualification and approval, management of internal/external audits, and notified body audits.
• Six Sigma Black Belt certification, with experience applying Six Sigma methods such as DFSS, DMAIC, and DoE.
• Experience in Design for Manufacturing and Assembly (DFMA) and reviewing tolerance analysis.
• Experience with simulated use, in-process, and finished testing for both non-electrical and electrical medical devices.
• Experience with catheter-based technologies and processes, with understanding of system-level interactions and integrations, including electrical, mechanical, and human interface risks, mitigations, and considerations