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 ID: 108523

Position Type: Full-time with HCLTech

Location: Madison, WI

Role/Responsibilities:

Purpose and Background

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

The role is requalifying probe manufacturing operations at its Madison, WI facility 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.

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

Scope of Work

Contracted engineers shall support the following project phases:

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 Operations and QA
• Collaborate with 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

Phase 3 – Production Stabilization

• 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 production operators and technicians on validated processes
• Participate in daily/weekly operations reviews and provide status updates to the Operations team
• Support transition of stabilized processes to the core 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

• The role will provide on-site access to the facility, system access (ERP, document control), and necessary tooling/equipment in a timely manner to support project milestones.
• All contractor personnel must complete site-specific safety, quality system, and confidentiality onboarding prior to beginning hands-on work.
• Contractors will work standard business hours on-site in Madison, WI.
• Quality system documentation (protocols, reports, WIs) must conform to document control procedures, templates, and naming conventions.
• Any changes to scope, timeline, or resource count require written approval from both parties prior to implementation.

Pay and Benefits

Pay Range Minimum: $46.0 per hour

Pay Range Maximum: $49.00 per hour

HCL is an equal opportunity employer, committed to providing equal employment opportunities to all applicants and employees regardless of race, religion, sex, color, age, national origin, pregnancy, sexual orientation, physical disability or genetic information, military or veteran status, or any other protected classification, in accordance with federal, state, and/or local law. Should any applicant have concerns about discrimination in the hiring process, they should provide a detailed report of those concerns to View email address on click.appcast.io for investigation.

Compensation and Benefits

A candidate’s pay within the range will depend on their work location, skills, experience, education, and other factors permitted by law. This role may also be eligible for performance-based bonuses subject to company policies. In addition, this role is eligible for the following benefits subject to company policies: medical, dental, vision, pharmacy, life, accidental death & dismemberment, and disability insurance; employee assistance program; 401(k) retirement plan; 10 days of paid time off per year (some positions are eligible for need-based leave with no designated number of leave days per year); and 10 paid holidays per year.

How You’ll Grow

At HCLTech, we offer continuous opportunities for you to find your spark and grow with us. We want you to be happy and satisfied with your role and to really learn what type of work sparks your brilliance the best. Throughout your time with us, we offer transparent communication with senior-level employees, learning and career development programs at every level, and opportunities to experiment in different roles or even pivot industries. We believe that you should be in control of your career with unlimited opportunities to find the role that fits you best.