Principal Manufacturing Engineers - Multiple Openings

Specializations: Laser & Ultrasonic Welding | Vision Systems | Pressure Decay Leak Testing & Test Systems

ATR International is seeking Principal Manufacturing Engineers for multiple opportunities with our medical device client. These positions will lead the development, implementation, validation, and optimization of specialized manufacturing processes and equipment.

Each opening focuses on one of the specializations below. Candidates should have expertise relevant to their selected specialization;
experience across all three areas is not required.

Key Responsibilities

- Serve as the primary technical expert within your specialization, supporting manufacturing processes from development through production.

- Design and improve manufacturing processes, procedures, equipment installations, tooling, fixtures, and production layouts.

- Lead equipment qualification and process validation activities, including IQ/OQ/PQ, in accordance with applicable FDA and ISO requirements.

- Define process specifications, acceptance criteria, critical parameters, and performance metrics.

- Partner with R&D, Quality, Regulatory, Operations, and Contract Manufacturing teams to implement manufacturing solutions.

- Troubleshoot complex process and equipment failures, lead root cause investigations, and implement sustainable corrective actions.

- Improve process capability, product quality, yield, cycle time, and manufacturing efficiency.

- Establish process controls and statistical process control strategies where applicable.

- Provide technical guidance and mentorship to engineering colleagues.

Specialization 1: Laser & Ultrasonic Welding

Responsibilities and Required Expertise

- Lead laser and ultrasonic welding process design, development, implementation, validation, and optimization.

- Define welding specifications, critical process parameters, process outputs, and acceptance criteria.

- Develop and execute validation studies covering weld strength, hermeticity, and visual inspection.

- Qualify welding equipment and establish process monitoring and control strategies.

- Resolve complex welding failures and improve weld quality, yield, cycle time, and process capability.

- Evaluate new welding technologies, equipment, and methods.

Preferred Experience

- Hands-on experience with Coherent, IPG Photonics, TRUMPF, Evosys, Branson, Herrmann, Dukane, Rinco, or equivalent systems.

- Experience with laser technologies such as Nd, fiber, diode, or CO2, and ultrasonic welding methods such as standard, multi-frequency, or continuous welding.

- Laser transmission welding of thermoplastic components.

- Hermetic sealing validation, leak testing, and weld inspection.

- Alternative plastic joining methods, including heat staking and vibration welding.

- Horn and fixture design, acoustic stack optimization, and MES integration with welding equipment.

Specialization 2: Vision Systems

Responsibilities and Required Expertise

- Lead vision system design, implementation, validation, and optimization across manufacturing lines.

- Develop, qualify, and validate vision inspection processes and equipment.

- Define system requirements, inspection acceptance criteria, and performance metrics.

- Troubleshoot complex vision system failures and implement corrective actions.

- Evaluate technologies that improve inspection capability, manufacturing yield, and throughput.

Preferred Experience

- MES integration with vision systems.

- Geometric dimensioning and tolerancing (GD&T) and optical measurement principles.

- Machine learning or AI-based vision inspection technologies.

- Experience supporting medical device Contract Manufacturers.

- Six Sigma Green Belt or Black Belt certification.

Specialization 3: Pressure Decay Leak Testing & Test Systems

Responsibilities and Required Expertise

- Lead the design, implementation, validation, and optimization of pressure decay leak testing and electrical/mechanical test systems.

- Define test specifications, acceptance criteria, and test parameters.

- Lead qualification and validation of test equipment, including IQ/OQ/PQ.

- Develop and execute test method validation studies, including repeatability, reproducibility, measurement system analysis, and Gage R&R.

- Improve test yield and cycle time while reducing false rejection rates.

- Investigate complex test failures and implement sustainable corrective actions.

- Evaluate new testing technologies and methods to improve manufacturing performance.

Preferred Experience

- Hands-on experience with Uson, Zaxis, Inficon, or equivalent leak testing equipment.

- Fluid dynamics, pneumatics, and hermetic sealing principles.

- Alternative leak testing methods, including mass flow, helium, and vacuum decay.

- MES integration with test equipment.

- Pump or infusion device manufacturing.

- Experience supporting medical device Contract Manufacturers.

- Six Sigma Green Belt or Black Belt certification.

Qualifications for All Positions

- Bachelor’s degree or equivalent with at least 7 years of relevant experience, or an advanced degree with at least 5 years of relevant experience.

- Deep technical expertise in the specialization relevant to the position.

- Experience developing, qualifying, validating, and optimizing manufacturing processes or equipment.

- Strong analytical, troubleshooting, and technical documentation skills.

- Ability to lead technical projects and collaborate across engineering, quality, manufacturing, and regulatory functions.

Additional Relevant Tools and Experience

- Microsoft Office, Minitab, document management systems, MES, AutoCAD, SolidWorks, and SAP.

- Experience supporting Contract Manufacturers in a medical device environment.

Please indicate your specialization when applying: Laser & Ultrasonic Welding, Vision Systems, or Pressure Decay Leak Testing & Test Systems.