Manufacturing Engineer

HCLTech is looking for a highly talented and self-motivated Manufacturing / Process Engineers to join it in advancing the technological world through innovation and creativity.

Job Title: Manufacturing / Process Engineers

Job : 108523

Position Type: Full-time with HCLTech

Location: Madison, WI

Role/Responsibilities:

Purpose and Background

Neu Wave Medical Inc, based in Madison, Wisconsin, develops and manufactures microwave ablation systems used to treat soft tissue tumors. The Neu Wave product portfolio includes the NEUWAVE Microwave Ablation System (Certus 140 / ABLATE-IQ platform) and a broad family of single-use microwave ablation probes spanning percutaneous and surgical applications.

Probe manufacturing currently occurs at an external contract manufacturer (Ethicon, Inc. – Ciudad Juárez, Mexico). Neu Wave is requalifying probe manufacturing operations at its Madison, WI facility (3513 Anderson Street – Operations, ~11,942 ft²) to establish local manufacturing capability, strengthen supply chain resilience, and support long-term growth. This effort requires establishing and validating a production line for the full current probe portfolio, qualifying the associated EtO sterilization supply chain (Sterigenics, Santa Teresa, NM), and stabilizing production output to commercial demand levels.

Neu Wave is engaging HCL Technologies to provide contract Manufacturing / Process Engineers embedded within the Neu Wave Operations team for the duration of this project.

Scope of Work

Phase 1 – Line Setup & Equipment Qualification

• Define equipment, fixture, tooling, and workstation requirements for probe assembly
• Coordinate procurement, installation, and configuration of production equipment.
• Author and execute Installation Qualification (IQ) and Operational Qualification (OQ) protocols for all production and test equipment
• Support establishment of the Packaging Controlled Manufacturing Environment (CME) requirements for probe assembly and packaging activities
• Author work instructions (WIs) and visual aids for all line setup and assembly operations
• Support supplier and vendor coordination for specialized components (coax cable, cannula sub-assemblies, thermocouple integration, LED indicators, connectors)

Phase 2 – Process Validation

• Develop and execute Performance Qualification (PQ) / Process Validation (PV) protocols per FDA 21 CFR Part 820 and ISO 13485 requirements
• Coordinate EtO sterilization validation activities with Sterigenics (Santa Teresa, NM) as required
• Support packaging validation (seal integrity, package integrity, accelerated aging) in coordination with Neu Wave Operations and QA
• Collaborate with Neu Wave QA on non-conformance documentation and CAPA activities arising during validation
• Author and compile validation summary reports for QA / regulatory review and batch disposition
• Coordinate environmental monitoring activities with Nelson Laboratories (Salt Lake City, UT) and Steris Laboratories (El Paso, TX) as applicable
• Support initial production runs across probe families; monitor process performance against validated parameters
• Identify and resolve manufacturing process issues (yield, cycle time, quality escapes, assembly variation across gauge/length variants)
• Develop and maintain process control documentation: control plans, PFMEAs, SOPs, and WIs covering the full probe portfolio
• Train Neu Wave production operators and technicians on validated processes
• Participate in daily/weekly operations reviews and provide status updates to the Neu Wave Operations team
• Support transition of stabilized processes to the core Neu Wave Operations team upon project close-out

Mandatory

• B.S. in Mechanical Engineering, Manufacturing Engineering, Biomedical Engineering, or related discipline
• 3+ years of manufacturing engineering experience in a regulated medical device or life sciences environment
• Hands-on experience authoring and executing IQ/OQ/PQ validation protocols
• Working knowledge of ISO 13485 and FDA 21 CFR Part 820 quality system requirements
• Proficiency in GD&T, technical drawing interpretation, and manufacturing process documentation
• Experience developing SOPs, work instructions, PFMEAs, and process control documentation

Preferred

• Experience with precision medical device assemblies involving coaxial cable, small-gauge needle/cannula, thermocouple integration, or RF/microwave antenna construction
• Familiarity with EtO sterilization validation processes, bioburden testing programs, and packaging qualification (ASTM F2097, ISO 11607)
• Experience with controlled manufacturing environment (CME) or cleanroom assembly operations (ISO Class 7/8)
• Statistical analysis skills (Minitab or equivalent); SPC, process capability (Cpk), and DOE experience
• Exposure to multi-SKU / family validation strategies covering gauge, length, and configuration variants
• PFMEA, control plan, and risk management experience per ISO 14971

Assumptions and Constraints

• Neu Wave will provide on-site access to the facility, system access (ERP, document control), and necessary…