Sr Manufacturing Engineer- Medical Devices

We are seeking a Senior Manufacturing Engineer with deep, hands-on expertise in medical device manufacturing to serve as a technical leader within our manufacturing organization. The ideal candidate will have 7-10 years of experience in medical device manufacturing engineering, with demonstrated, specific expertise in catheter and balloon catheter manufacturing processes (including balloon forming, catheter shaft extrusion, tipping, bonding, and related assembly operations). This role acts as the senior technical authority on complex, high-risk manufacturing processes, driving process development, transfer, and continuous improvement independently and with minimal oversight, while mentoring junior engineers on catheter and balloon-specific manufacturing techniques. This is an individual-contributor role with no formal direct reports. 

DUTIES AND RESPONSIBILITIES: 

• Catheter & Balloon Process Leadership: Serve as the senior subject-matter expert for catheter and balloon catheter manufacturing, including balloon forming/blow molding, compliance and burst testing, extrusion, tipping, skiving, marker band placement, shaft bonding, and RF/laser welding processes. 

• Advanced Process Development & Optimization: Independently design, develop, and optimize complex manufacturing processes for electro-mechanical devices and single-use disposable products, applying DOE, SPC, and lean methodologies to drive first-pass yield and throughput improvements. 

• New Product Introduction (NPI) & Design Transfer: Lead manufacturing readiness activities for new catheter and balloon-based products, partnering with R&D to transfer designs from development into scalable, validated production. 

• Technical Documentation & Design Controls: Author and approve manufacturing procedures, work instructions, SOPs, and process specifications; lead risk analysis, DHF contributions, and validation/verification protocols in compliance with FDA regulations and ISO 13485. 

• Fixture, Tooling & Automation Design: Lead the design, development, and qualification of manufacturing fixtures, tooling, and semi/fully-automated equipment for catheter and balloon assembly, ensuring compliance with design controls. 

• Process Validation Leadership: Own and lead IQ/OQ/PQ validation strategy and execution for new and existing catheter/balloon manufacturing processes and equipment. 

• Root Cause Analysis & CAPA Leadership: Lead complex root cause investigations, drive corrective and preventive actions (CAPA), and champion continuous improvement initiatives across the production floor. 

• ERP System Ownership: Utilize and oversee accuracy of the Epicor ERP system for Bills of Materials (BOMs), routing operations, work orders, inventory management, and production planning. 

• Cross-Functional & Supplier Leadership: Act as the primary manufacturing engineering point of contact with Quality Assurance, Regulatory Affairs, R&D, and key suppliers on catheter/balloon component and material qualification. 

• Regulatory Compliance: Ensure all manufacturing processes comply with FDA 21 CFR Part 820, ISO 13485, ISO 14971, and other applicable medical device regulations. 

• Mentoring & Technical Training: Mentor and train junior and mid-level manufacturing engineers and production personnel on catheter/balloon manufacturing techniques, process troubleshooting, and best practices, without formal supervisory authority. 

• Production Support: Serve as the escalation point for complex production floor issues, troubleshooting and implementing solutions to maintain production schedules and quality targets. 

• Other duties and projects assigned. 

QUALIFICATIONS: 

• Education: Bachelor's degree in Manufacturing Engineering, Mechanical Engineering, Biomedical Engineering, or related technical field required; Master's degree a plus. 

• Experience: 7-10 years of experience in medical device manufacturing engineering, including significant, hands-on experience with catheter and balloon catheter manufacturing (balloon forming/blow molding, extrusion, tipping, bonding, and related processes) — required. Proven experience with electro-mechanical device assembly and testing. Demonstrated experience with Epicor ERP or similar ERP software. Extensive experience in FDA-regulated manufacturing environments, including leading process validations and design transfers. 

• Technical Skills: Advanced proficiency in CAD software (SolidWorks, AutoCAD, or similar); strong command of statistical process control (SPC), Design of Experiments (DOE), and lean manufacturing principles; deep understanding of medical device design controls and validation processes; extensive experience leading IQ/OQ/PQ process validation. 

• Regulatory Knowledge: Thorough understanding of FDA 21 CFR Part 820 Quality System Regulation; expert knowledge of ISO 13485; strong familiarity with ISO 14971 Risk Management; solid understanding of ISO 10993 biocompatibility requirements. 

COMPETENCIES: 

• Technical Leadership — Recognized as the go-to technical authority on catheter and balloon manufacturing processes; able to guide engineering decisions without formal authority. 

• Problem Solving — Advanced analytical and critical thinking skills with a track record of resolving complex, ambiguous manufacturing problems independently. 

• Project Management — Able to independently plan and drive multiple concurrent, high-complexity projects with competing priorities to completion. 

• Mentorship — Willingness and ability to coach and develop junior engineers and technicians, sharing catheter/balloon-specific process knowledge. 

• Communication — Excellent written and verbal communication skills, including the ability to present technical rationale to cross-functional and leadership audiences. 

• Attention to Detail — Meticulous focus on quality, patient safety, and regulatory compliance in all aspects of work. 

• Adaptability — Comfortable operating in a fast-paced environment with shifting priorities and evolving product requirements. 

• Quality Mindset — Deep commitment to quality excellence and patient safety, particularly in high-risk catheter and balloon device manufacturing. 

PHYSICAL DEMANDS AND WORK ENVIRONMENT: 

Physical Requirements: 

• Ability to stand and walk for extended periods on the manufacturing floor. 

• Capability to lift up to 25 pounds occasionally. 

• Manual dexterity required for handling small components and operating precision equipment. 

• Visual acuity necessary for inspecting small medical device components, including catheter and balloon assemblies. 

• Ability to work in various positions including standing, sitting, bending, and reaching. 

Work Environment: 

• Clean room manufacturing environment requiring adherence to gowning procedures. 

• Exposure to manufacturing equipment and potential noise levels requiring hearing protection. 

• Occasional exposure to chemicals and cleaning agents used in medical device manufacturing. 

• Temperature-controlled environment with potential for both warm and cool areas. 

• May require occasional travel to supplier locations or other company facilities (up to 10%). 

• Standard business hours with occasional overtime during critical project phases or production issues. 

Safety Requirements: 

• Must comply with all company safety policies and procedures. 

• Required to wear appropriate Personal Protective Equipment (PPE) including safety glasses, gloves, and clean room attire. 

• Participation in regular safety training and emergency response procedures. 

• Health Care Plan (Medical, Dental & Vision)
• Retirement Plan with Company Match
• Paid Time Off, Personal Days, AND Birthday Holiday!
• Lifetime Membership Subsidy and Wellness Resources
• Life Insurance (Basic, Voluntary & AD&D)
• Family Leave (Maternity, Paternity)
• Short-Term & Long-Term Disability
• Taco Thursdays!!!

Nextern is an equal opportunity employer. We encourage applications from candidates of all backgrounds and experiences, and we are committed to fostering an inclusive and diverse workplace. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.