Senior Engineer, Catheter NPI & Manufacturing

The Senior Engineer, Catheter NPI & 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 & CMO Externalization

• Lead end-to-end transfer of catheter products from R&D to established contract manufacturers, including planning, execution, and post-transfer stabilization.
• Develop and own comprehensive technology transfer packages (process flows, BOMs, work instructions, equipment specifications, test methods, and training materials).
• Ensure full alignment between DHF and DMR, with clear translation of design outputs into manufacturable specifications at the CMO.
• Define transfer strategy including build plan (alpha, pilot, validation, ramp) and success criteria.
• Establish manufacturing equivalency between internal development builds and CMO production.

Manufacturing Fixture & Tooling Development

• Design, develop, and qualify custom manufacturing fixtures and tooling to support catheter assembly processes (e.g., bonding, alignment, tipping, reflow).
• Translate process requirements into fixture design specifications, including tolerance stack-ups, alignment constraints, thermal considerations, and operator interaction.
• Develop rapid prototype fixtures (e.g., 3D printed, machined) to support engineering builds and process development.
• Collaborate with internal teams and/or CMOs to transition prototype fixtures into production-ready tooling.
• Generate and maintain fixture documentation packages (drawings, BOMs, work instructions, maintenance requirements).
• Ensure fixtures are scalable, repeatable, and suitable for transfer to manufacturing environments.

CMO Readiness & Qualification Execution

• Partner with Supply Chain and Quality to support CMO onboarding and qualification activities.
• Execute technical capability assessments and gap closure plans for assigned CMOs.
• Define equipment, tooling, and infrastructure requirements to enable successful transfer.
• Support first article inspection (FAI) and process qualification readiness.
• Ensure CMO alignment with FDA QSR, ISO 13485, and internal quality requirements.

Process Development, Industrialization & Validation

• Transfer and scale catheter manufacturing processes (e.g., bonding, shaft assembly, tipping, coating, extrusion interfaces) to CMO environments.

· Author and execute protocols and reports for design verification & design validation activities. This includes shelf-life packaging testing, product functionality and performance testing.

• Author and execute process validation (IQ/OQ/PQ) at the CMO, including protocol development, execution oversight, and report approval.
• Develop and industrialize catheter manufacturing processes, including design and integration of fixtures and tooling required to ensure repeatability and scalability.
• Incorporate fixtures into process validation activities (IQ/OQ/PQ), ensuring they are qualified and capable of consistently meeting process requirements.
• Define and monitor critical process parameters (CPPs) and critical quality attributes (CQAs).
• Ensure appropriate process controls, in-line inspection methods, and SPC systems are implemented at the CMO.
• Drive process robustness and repeatability across sites.

Build Execution & Production Ramp

• Plan and execute engineering builds, pilot builds, and validation builds at the CMO.
• Transfer fixture designs and tooling requirements to contract manufacturers, ensuring accurate replication and implementation.
• Provide on-site technical support during builds, including troubleshooting and operator training.
• Establish yield targets, scrap reduction plans, and ramp metrics.
• Drive resolution of build issues through structured root cause analysis (DOE, 5-Why, Fishbone).
• Transition ownership to sustaining teams post-launch with clear handoff criteria.

Supplier & CMO Performance Management

• Serve as primary technical interface between Arga and CMO engineering/manufacturing teams.
• Establish and monitor KPIs (yield, cycle time, cost, quality) for CMO performance.
• Lead continuous improvement and value engineering initiatives with CMOs.
• Support and resolve NCR, CAPA, and deviation investigations related to CMO production.
• Drive change management (ECO/ECN) implementation across internal and external stakeholders.

Cross-Functional Leadership & Compliance

• Partner with Quality, Regulatory, and Supply Chain to ensure compliant and efficient product transfer.
• Support regulatory submissions and audits related to manufacturing transfer or process changes.
• Lead risk management activities (PFMEA, control plans) specific to CMO processes.
• Ensure all activities meet design control and quality system requirements.

Documentation & Systems

• Develop and maintain DMR, process documentation, work instructions, and training materials at the CMO.
• Ensure traceability between design requirements, process controls, and inspection methods.
• Review and approve CMO-generated documentation for alignment with product requirements.

EXPERIENCE & QUALIFICATIONS:

· Bachelor’s Degree in Mechanical Engineering, Biomedical Engineering, or related field, or equivalent experience.

· 10+ years of experience in medical device engineering with strong emphasis on NPI, design transfer, and CMO execution.

· Proven track record of successful product transfer to contract manufacturers, including validation and commercial ramp.

· Deep expertise in catheter manufacturing processes and materials.

· Proven experience designing and implementing fixture-driven process solutions for catheter or complex assembly manufacturing.

· Strong experience with process validation (IQ/OQ/PQ), DOE, SPC, and statistical methods.

· Experience working with global CMOs and supplier networks.

· Working knowledge of CAD tools including experience with SolidWorks.

· Strong understanding of FDA QSR, ISO 13485, and regulatory expectations.

· Strong understanding of ISO 10555-1.

· Experience supporting regulatory submissions, audits, and inspections related to manufacturing sites.

· Demonstrated leadership in cross-functional and matrixed environments.

· Experience managing engineers or technical teams preferred.

Pay: From $120,000.00 per year

Benefits:

• 401(k)
• Health insurance
• Paid time off

Application Question(s):

• What is your desired salary?
• How many years of experience in medical device engineering with emphasis on NPI, Design transfer, and CMO execution do you have?
• How many years have you worked with catheters?

Work Location: In person