Manufacturing Engineer

ATR International; Milwaukee (WI); On-site; USD 85,000 - 115,000; Full time

Job summary

ATR International seeks a Manufacturing Engineer (MDR) to design, optimize, and validate robust manufacturing processes and facility layouts. You will advance existing technologies and introduce new concepts to ensure high-efficiency production, product performance, and regulatory compliance.

As a seasoned individual contributor, you will drive process improvements, lead equipment validations, apply Lean Six Sigma methodologies, and mentor junior engineering staff while collaborating with R&D

Qualifications

• Hands-on equipment validation using IQ/OQ/PQ protocols.
• Experience with Gauge R&R studies and DoE.
• Proficiency in ISO 13485 and FDA Design Controls (21 CFR Part 820).

Responsibilities

• Design efficient manufacturing processes and layouts to optimize plant productivity.
• Adapt machine designs and specify fabrication procedures for tools and equipment.
• Develop production plans with inspection, testing, and SPC integration.
• Inspect equipment and implement CAPA to maintain quality.
• Guide R&D and Design Engineering on manufacturability and equipment capabilities.
• Ensure processes and documentation comply with regulatory standards.
• Lead manufacturing projects from concept to implementation and mentor staff.
• Operate as a seasoned individual contributor under limited supervision.

Skills

Lean Six Sigma

Root Cause Analysis

DMAIC

5-Whys

SPC

Education

Bachelor’s Degree in Mechanical/Manufacturing/Industrial Engineering

Master’s Degree

PhD

Tools

IQ/OQ/PQ protocols

Gauge R&R studies

Design of Experiments (DoE)

Job description

We are seeking a Manufacturing Engineer (MDR) to design, optimize, and validate robust manufacturing processes and facility layouts. In this role, you will advance existing technologies and introduce new manufacturing concepts to ensure high-efficiency production, product performance, and regulatory compliance. As a seasoned individual contributor, you will drive process improvements, lead equipment validations, apply Lean Six Sigma methodologies, and mentor junior engineering staff.

Key Responsibilities

• Process & Layout Design: Design efficient manufacturing processes, production layouts, equipment installations, sequence of operations, and material handling systems to optimize plant productivity.
• Equipment & Tooling Adaptation: Adapt machine and equipment designs to factory and production conditions; specify fabrication procedures for custom tools and equipment.
• Validation & Quality Integration: Develop and execute production plans that integrate inspection, testing, and Statistical Process Control (SPC) requirements.
• Equipment Maintenance & Troubleshooting: Inspect equipment, machinery, and tooling performance; investigate failures; and implement corrective actions (CAPA) to maintain high product quality.
• Cross-Functional Design Support: Provide guidance to R&D and Design Engineering regarding manufacturing feasibility, DFM (Design for Manufacturability), and equipment capabilities.
• Regulatory Compliance: Ensure all manufacturing processes, procedures, and documentation comply with relevant industry standards and regulatory bodies.
• Project Delivery & Mentorship: Lead assigned manufacturing projects from concept to implementation, managing project schedules and directing/coaching lower-level technical professionals.
• Autonomy: Operates as a seasoned individual contributor under limited supervision. Independently determines and executes approaches to engineering solutions.
• Organizational Impact: Manages key projects or process areas within manufacturing, building cross-functional consensus to achieve department objectives.
• Innovation & Complexity: Solves complex, multi-faceted engineering problems. Performs in-depth root cause analysis and recommends systemic improvements.
• Communication & Influence: Communicates effectively with senior internal stakeholders, external vendors, and regulatory auditors to influence technical decision-making.
• Leadership: Mentors, trains, and provides daily technical guidance to junior specialists; delegates and reviews project work products.

Required Qualifications & Experience

Must-Have Requirements

• Equipment Validation: Hands-on experience with IQ/OQ/PQ protocols, Gauge R&R studies, and Design of Experiments (DoE).
• Lean Six Sigma & Root Cause Analysis: Proficiency with DMAIC, FMEA (PFMEA), 5-Whys, Fishbone diagrams, and SPC tools.
• Regulated Environment Experience: Proven track record working under ISO 13485 and/or FDA Design Controls (21 CFR Part 820).

Education & Experience Benchmarks

• Bachelor’s Degree in Mechanical, Manufacturing, Biomedical, or Industrial Engineering (or related technical field) with 4+ years of relevant experience; OR
• Master’s Degree with 2+ years of relevant experience; OR
• PhD with 0+ years of relevant experience.