Senior Manufacturing Engineer – Medical Devices (MDR)

ATR International; Milwaukee (WI); On-site; USD 90,000 - 140,000; Full time

Job summary

ATR International is seeking a Senior Manufacturing Engineer in Milwaukee to support process development, equipment validation, and continuous improvement in a regulated medical device environment.

Responsibilities include designing and improving processes, executing IQ/OQ/PQ validation, applying Lean Six Sigma methods, and guiding junior engineers while collaborating with quality, engineering, and operations teams to enhance efficiency and product quality.

Qualifications

• Bachelor’s degree or higher with related experience in manufacturing engineering.
• Experience with validation of equipment including IQ/OQ/PQ and measurement methods.
• Familiarity with ISO 13485 and FDA quality systems in medical device manufacturing.
• Able to solve complex problems and manage projects with limited supervision.
• Strong documentation and cross-functional collaboration skills.

Responsibilities

• Design and improve manufacturing processes, layouts, and equipment installation plans.
• Plan and execute IQ/OQ/PQ validation activities for equipment and processes.
• Apply Gauge R&R, DOE, and SPC to evaluate performance and drive improvements.
• Investigate issues, identify root causes, and implement corrective actions.
• Use Lean Six Sigma tools (DMAIC, FMEA, 5 Whys) to reduce variation.
• Develop manufacturing docs, work instructions, and procedures conforming to quality.regulatory specs.
• Incorporate inspection and testing requirements into production processes.
• Collaborate with engineering to ensure designs support manufacturing, and lead projects.
• Provide guidance and coaching to less experienced engineers.
• Coordinate with cross-functional stakeholders and vendors for project success.

Skills

Lean Six Sigma

Root cause analysis

Cross-functional collaboration

Documentation

IQ/OQ/PQ validation

Gauge R&R

DOE

SPC

DMAIC

FMEA

Education

Bachelor’s degree in Engineering

Master’s degree (preferred)

PhD (relevant)

Job description

We are seeking a Senior Manufacturing Engineer to support manufacturing process development, equipment validation, and continuous improvement in a regulated medical device environment. This role will partner with engineering, quality, and operations teams to improve manufacturing efficiency, equipment performance, and product quality.

Key Responsibilities

• Design and improve manufacturing processes, procedures, production layouts, and equipment installation plans.
• Plan and execute equipment and process validation activities, including IQ/OQ/PQ.
• Apply Gauge R&R, Design of Experiments (DOE), and statistical process control (SPC) to evaluate manufacturing performance and support process improvements.
• Investigate equipment and process issues, identify root causes, and implement corrective actions.
• Use Lean Six Sigma methodologies, including DMAIC, FMEA, and 5 Whys, to reduce variation and improve manufacturing efficiency.
• Develop manufacturing documentation, work instructions, and procedures that meet quality and regulatory requirements.
• Incorporate inspection and testing requirements into production processes.
• Collaborate with engineering teams to ensure product designs and specifications support effective manufacturing.
• Lead assigned projects and coordinate with cross-functional stakeholders and vendors.
• Provide technical guidance, coaching, and support to less experienced engineers.

Required Qualifications

• Bachelor’s degree with at least 4 years of relevant experience; master’s degree with at least 2 years of relevant experience; or PhD with 0 years of relevant experience.
• Hands-on experience with equipment validation and qualification, including IQ/OQ/PQ.
• Experience with statistical and measurement methods such as Gauge R&R and DOE.
• Working knowledge of Lean Six Sigma and root cause analysis methods, including DMAIC, FMEA, and 5 Whys.
• Experience working in a regulated manufacturing environment and familiarity with ISO 13485 and FDA quality system/design control requirements.
• Ability to independently solve complex manufacturing problems and manage projects with limited supervision.
• Strong technical documentation, communication, and cross-functional collaboration skills.

Preferred Qualifications

• Experience supporting medical device manufacturing.
• Experience with manufacturing process development, equipment implementation, and production layout optimization.
• Experience applying SPC to monitor and improve process performance.
• Experience mentoring engineers or leading cross-functional improvement initiatives.