Job Title: Principal Catheter Process Manufacturing Engineer
Pay: $160,000 - $180,000
Reports to: Sr. VP of Manufacturing & Operations
POSITION OVERVIEW
The Principal Catheter Process Manufacturing Engineer is a technical leader responsible for developing, optimizing, validating, and scaling manufacturing processes for complex Class II and Class III catheter-based medical devices. This role serves as the organization's subject matter expert (SME) for catheter manufacturing technologies, providing strategic and hands-on leadership from new product introduction (NPI) through commercial production. Working cross-functionally with Research & Development, Quality, Regulatory Affairs, Supply Chain, Operations, and Contract Manufacturing Organizations (CMOs/CDMOs), this individual will develop robust, repeatable, and cost[1]effective manufacturing processes that deliver exceptional product quality, regulatory compliance, and operational excellence.
ESSENTIAL DUTIES
- Manufacturing & Process Development - Lead the development, optimization, validation, and commercialization of catheter manufacturing processes.
- Design scalable manufacturing processes supporting prototype, clinical, pilot, and commercial production.
- Provide technical leadership for complex catheter assembly processes including shaft assembly, braiding, lamination, reflow, heat shrink, thermal bonding, adhesive bonding, laser processing, tip assembly, pull-wire integration, steering mechanisms, and precision catheter assembly.
- Develop and implement manufacturing strategies that improve quality, throughput, capacity, and cost.
- Process Validation & Continuous Improvement - Lead process validation activities including IQ, OQ, PQ, process characterization, Design of Experiments (DOE), Gage R&R, and statistical capability studies.
- Drive continuous improvement initiatives focused on first-pass yield, scrap reduction, cycle time improvements, process capability, labor efficiency, and Overall Equipment Effectiveness (OEE).
- Utilize Lean Manufacturing and Six Sigma methodologies to identify and eliminate process variation and manufacturing inefficiencies.
- Manufacturing Scale-Up & Technology Transfer - Lead Design Transfer, manufacturing scale-up, and technology transfer activities from R&D through commercial production. - Support manufacturing transfers to domestic and international CMOs/CDMOs while ensuring process consistency and compliance.
- Develop manufacturing readiness plans, capacity models, and production strategies to support business growth.
- Technical Leadership - Serve as the technical authority for catheter manufacturing processes across the organization.
- Mentor Manufacturing and Process Engineers while providing technical guidance to production personnel.
- Lead cross-functional engineering projects and complex root cause investigations using structured problem-solving methodologies.
- Quality & Regulatory Compliance - Ensure manufacturing processes comply with FDA Quality System Regulations, ISO 13485, ISO 14971, GMP, and applicable international regulatory requirements.
- Develop and maintain manufacturing documentation including SOPs, work instructions, validation protocols, engineering specifications, control plans, and engineering change documentation.
- Participate in internal, supplier, and regulatory audits while supporting CAPA and risk management activities.
- Performs other duties as required or as assigned by supervisor.
TECHNICAL SKILLS
- Catheter Manufacturing & Assembly: EP catheters, RF ablation, cryoablation/cold ablation, steerable catheters preferred
- Polymer Processing & Thermal Forming
- Braiding, Lamination & Reflow Processes
- Precision Adhesive Bonding
- Process Validation (IQ/OQ/PQ)
- Design of Experiments (DOE)
- Statistical Process Control (SPC)
- Lean Manufacturing & Six Sigma
- Root Cause Analysis & Risk Management
- Manufacturing Automation & Fixture Design
- Process Capability (Cp/Cpk)
- FDA, ISO 13485, ISO 14971 & GMP Compliance
- Strategic Manufacturing Leadership
- Cross-Functional Collaboration
- Technical Mentorship
- Project & Program Leadership
- Data-Driven Decision Making
- Continuous Improvement
- Excellent Written and Verbal Communication
- Strong Analytical and Problem-Solving Skills
QUALIFICATIONS
- B.S. in Engineering (ie. Mechanical, Biomedical, or Manufacturing). Master’s degree a plus.
- 10+ years of medical device manufacturing engineering experience. Demonstrated experience with Class II or Class III medical devices and high-volume precision medical device manufacturing. 8+ years supporting complex catheter manufacturing.
- Extensive experience leading manufacturing process development, validation, and commercialization.
- Proven success supporting manufacturing scale-up and technology transfer.
- Experience working with Contract Manufacturing Organizations (CMOs/CDMOs).
- Experience with Electrophysiology (EP) catheters, Ablation catheter manufacturing, Cryogenic or RF energy delivery systems, Steerable catheter technologies preferred.
- Experience working with global CDMO/CMO partners, including supplier development, technology transfer, and production scale-up activities across Asia and Latin America preferred.
- Experience leading cross-cultural teams and managing international manufacturing relationships in regulated environments preferred.
- Experience in start-up environments a plus.
TRAVEL REQUIREMENTS
Up to 20% domestic and international travel may be required to support suppliers, manufacturing partners, and technology transfer activities.
PHYSICAL REQUIREMENTS
The role requires frequent engagement within a manufacturing environment, characterized by varying noise levels. Success requires an ability to maintain focus and lead teams effectively within these environments. Prolonged periods of sitting stationary with the use of a computer and/or other office equipment required. Occasional standing with the ability to traverse tight spaces and maneuver up to 25lbs required.
This employer participates in E-Verify, a federal program to confirm the employment eligibility of new hires. If you have any questions about the E-Verify process or your rights, please visit the E-Verify website or contact Human Resources.
Consistent with the Americans with Disabilities Act (ADA), CDPA, and FEHA, it is the policy of Adagio Medical to provide reasonable accommodation when requested by a qualified applicant or candidate with a disability, unless such accommodation would cause an undue hardship for the company. The policy regarding requests for reasonable accommodation applies to all aspects of the hiring process. If reasonable accommodation is required, please contact [email protected].
Adagio Medical is committed to creating an inclusive and equitable workplace where all individuals are valued and receive equal opportunities for employment and advancement, regardless of their race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected status or characteristic.
Pay: $160,000.00 - $180,000.00 per year
Benefits:
- 401(k)
- Dental insurance
- Health insurance
- Life insurance
- Paid time off
- Vision insurance
Application Question(s):
- Will you now or in the future require sponsorship to accept or continue working in this role (ie. F1, CPT, OPT, H1B, etc)? Please note that Adagio Medical does not sponsor visas.
Experience:
- hands-on catheter : 10 years (Required)
Willingness to travel:
Work Location: In person
