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Mosaic People Solutions on Behalf of Client

The Senior Engineer, Catheter NPI &amp; Manufacturing is responsible for leading the transfer, scale-up, and commercialization of catheter-based medical devices to contract manufacturers (CMOs) for Arga Medtech Inc. This role ensures successful externalization of manufacturing through robust design transfer, process validation, and supplier integration. Develops technical solutions to complex manufacturing challenges and works cross-functionally to ensure CMOs are fully capable, qualified, and scalable for commercial production.ESSENTIAL DUTIES AND RESPONSIBILITIES:Design Transfer &amp; CMO Externalization<ul><li>Lead end-to-end transfer of catheter products from R&amp;D to established contract manufacturers, including planning, execution, and post-transfer stabilization.</li><li>Develop and own comprehensive technology transfer packages (process flows, BOMs, work instructions, equipment specifications, test methods, and training materials).</li><li>Ensure full alignment between DHF and DMR, with clear translation of design outputs into manufacturable specifications at the CMO.</li><li>Define transfer strategy including build plan (alpha, pilot, validation, ramp) and success criteria.</li><li>Establish manufacturing equivalency between internal development builds and CMO production.</li></ul>Manufacturing Fixture &amp; Tooling Development<ul><li>Design, develop, and qualify custom manufacturing fixtures and tooling to support catheter assembly processes (e.g., bonding, alignment, tipping, reflow).</li><li>Translate process requirements into fixture design specifications, including tolerance stack-ups, alignment constraints, thermal considerations, and operator interaction.</li><li>Develop rapid prototype fixtures (e.g., 3D printed, machined) to support engineering builds and process development.</li><li>Collaborate with internal teams and/or CMOs to transition prototype fixtures into production-ready tooling.</li><li>Generate and maintain fixture documentation packages (drawings, BOMs, work instructions, maintenance requirements).</li><li>Ensure fixtures are scalable, repeatable, and suitable for transfer to manufacturing environments.</li></ul>CMO Readiness &amp; Qualification Execution<ul><li>Partner with Supply Chain and Quality to support CMO onboarding and qualification activities.</li><li>Execute technical capability assessments and gap closure plans for assigned CMOs.</li><li>Define equipment, tooling, and infrastructure requirements to enable successful transfer.</li><li>Support first article inspection (FAI) and process qualification readiness.</li><li>Ensure CMO alignment with FDA QSR, ISO 13485, and internal quality requirements.</li></ul>Process Development, Industrialization &amp; Validation<ul><li>Transfer and scale catheter manufacturing processes (e.g., bonding, shaft assembly, tipping, coating, extrusion interfaces) to CMO environments.</li></ul>&middot; Author and execute protocols and reports for design verification &amp; design validation activities. This includes shelf-life packaging testing, product functionality and performance testing.<ul><li>Author and execute process validation (IQ/OQ/PQ) at the CMO, including protocol development, execution oversight, and report approval.</li><li>Develop and industrialize catheter manufacturing processes, including design and integration of fixtures and tooling required to ensure repeatability and scalability.</li><li>Incorporate fixtures into process validation activities (IQ/OQ/PQ), ensuring they are qualified and capable of consistently meeting process requirements.</li><li>Define and monitor critical process parameters (CPPs) and critical quality attributes (CQAs).</li><li>Ensure appropriate process controls, in-line inspection methods, and SPC systems are implemented at the CMO.</li><li>Drive process robustness and repeatability across sites.</li></ul>Build Execution &amp; Production Ramp<ul><li>Plan and execute engineering builds, pilot builds, and validation builds at the CMO.</li><li>Transfer fixture designs and tooling requirements to contract manufacturers, ensuring accurate replication and implementation.</li><li>Provide on-site technical support during builds, including troubleshooting and operator training.</li><li>Establish yield targets, scrap reduction plans, and ramp metrics.</li><li>Drive resolution of build issues through structured root cause analysis (DOE, 5-Why, Fishbone).</li><li>Transition ownership to sustaining teams post-launch with clear handoff criteria.</li></ul>Supplier &amp; CMO Performance Management<ul><li>Serve as primary technical interface between Arga and CMO engineering/manufacturing teams.</li><li>Establish and monitor KPIs (yield, cycle time, cost, quality) for CMO performance.</li><li>Lead continuous improvement and value engineering initiatives with CMOs.</li><li>Support and resolve NCR, CAPA, and deviation investigations related to CMO production.</li><li>Drive change management (ECO/ECN) implementation across internal and external stakeholders.</li></ul>Cross-Functional Leadership &amp; Compliance<ul><li>Partner with Quality, Regulatory, and Supply Chain to ensure compliant and efficient product transfer.</li><li>Support regulatory submissions and audits related to manufacturing transfer or process changes.</li><li>Lead risk management activities (PFMEA, control plans) specific to CMO processes.</li><li>Ensure all activities meet design control and quality system requirements.</li></ul>Documentation &amp; Systems<ul><li>Develop and maintain DMR, process documentation, work instructions, and training materials at the CMO.</li><li>Ensure traceability between design requirements, process controls, and inspection methods.</li><li>Review and approve CMO-generated documentation for alignment with product requirements.</li></ul>EXPERIENCE &amp; QUALIFICATIONS:&middot; Bachelor&rsquo;s Degree in Mechanical Engineering, Biomedical Engineering, or related field, or equivalent experience.&middot; 10+ years of experience in medical device engineering with strong emphasis on NPI, design transfer, and CMO execution.&middot; Proven track record of successful product transfer to contract manufacturers, including validation and commercial ramp.&middot; Deep expertise in catheter manufacturing processes and materials.&middot; Proven experience designing and implementing fixture-driven process solutions for catheter or complex assembly manufacturing.&middot; Strong experience with process validation (IQ/OQ/PQ), DOE, SPC, and statistical methods.&middot; Experience working with global CMOs and supplier networks.&middot; Working knowledge of CAD tools including experience with SolidWorks.&middot; Strong understanding of FDA QSR, ISO 13485, and regulatory expectations.&middot; Strong understanding of ISO 10555-1.&middot; Experience supporting regulatory submissions, audits, and inspections related to manufacturing sites.&middot; Demonstrated leadership in cross-functional and matrixed environments.&middot; Experience managing engineers or technical teams preferred.Pay: From $120,000.00 per yearBenefits:<ul><li>401(k)</li><li>Health insurance</li><li>Paid time off</li></ul>Application Question(s):<ul><li>What is your desired salary?</li><li>How many years of experience in medical device engineering with emphasis on NPI, Design transfer, and CMO execution do you have?</li><li>How many years have you worked with catheters? </li></ul>Work Location: In person

Senior Engineer, Catheter NPI & Manufacturing

About the Opportunity A venture-backed medical device company is developing a novel therapy platform for treating complex cardiac disorders.The company has demonstrated promising early results and is now advancing toward a clinically deployable system. This is a rare opportunity to join a highly technical, mission-driven team working at the intersection of machine learning, control systems, and human physiology.Role OverviewThis role will lead the development of an adaptive, reinforcement learning&ndash;based control system within a dynamic and partially observable biological environment.You will work on a complex sequential decision-making problem, where the system must interpret high-dimensional physiological signals, predict outcomes of interventions, and continuously optimize performance in real time.The role includes both simulation-based development and collaboration with experimental teams to translate algorithms into real-world applications.Key Responsibilities<ul><li>Design and implement reinforcement learning algorithms for adaptive control</li><li>Develop state representations and reward functions for complex physiological systems</li><li>Build and evaluate model-based, offline, or constrained RL approaches</li><li>Utilize simulation environments to train, test, and validate algorithms</li><li>Develop signal processing pipelines for time-series physiological data</li><li>Apply control theory principles to ensure system stability and safety</li><li>Partner cross-functionally with engineering and research teams to support system development and validation</li></ul>Required Qualifications<ul><li>MS or PhD in Electrical Engineering, Computer Science, Biomedical Engineering, or related field</li><li>Strong expertise in reinforcement learning and/or control systems</li><li>Experience with Python (e.g., PyTorch, TensorFlow)</li><li>Background in signal processing and time-series analysis</li><li>Experience working with complex, dynamic systems</li></ul>Preferred Qualifications<ul><li>Experience applying ML/RL to physical or safety-critical systems (e.g., robotics, autonomous systems)</li><li>Exposure to healthcare, medical devices, or physiological data</li><li>Familiarity with optimization methods (e.g., Bayesian optimization, evolutionary algorithms)</li><li>Understanding of system validation, robustness, and safety considerations</li></ul>Pay: From $100,000.00 per yearBenefits:<ul><li>Health insurance</li></ul>Work Location: In person

AI / Reinforcement Learning Engineer

Join Mosaic People Solutions on Behalf of Client and explore 2   exciting career opportunities. They're hiring for various roles with options for remote or on-site work. Apply today and become part of their innovative team.

Mosaic People Solutions on Behalf of Client

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Senior Engineer, Catheter NPI & Manufacturing

AI / Reinforcement Learning Engineer