Process Automation Engineer

4 weeks ago

West Boylston, United States ZealoTech People Full time

Job Overview:

A provider of turnkey manufacturing services for medical OEMs, is seeking a skilled and experienced Operations Process Engineer (OPE) to join our team. The OPE will play a crucial role in providing leadership and support to manufacturing operations in our FDA & ISO 13485 regulated medical device manufacturing facility.

2.0 Responsibilities:

2.1 Development and Optimization of Manufacturing Processes:

Lead the development and optimization of manufacturing processes from inception through start-up, validation, and full-scale production.

Utilize Certified SolidWorks Professional Mechanical Design (CSWP) proficiency to contribute to detailed design and product development.

2.2 Engineering Analysis and Process Improvement:

Perform engineering analysis of process performance, identifying opportunities for improvement with a focus on safety, efficiency, and risk mitigation.

Utilize statistical techniques and tools like Minitab to enhance manufacturing quality.

2.3 Continuous Improvement and Lean Manufacturing:

Lead and support Continuous Improvement activities, including Kaizens, process improvements, and structured problem-solving events.

Design and plan cell layouts for Operational Excellence using lean manufacturing tools and techniques.

2.4 Process Validation and Project Management:

Lead or support engineering functions during IQ, OQ, PQ process validations.

Provide project management and technical support for plantwide process improvement projects.

2.5 Qualifications:

2.5.1 Essential Requirements:

Master of Science in Mechanical Engineering; BSME or related engineering discipline.

Exp of Manufacturing/Process engineering experience.

Proficiency in SolidWorks, AutoCAD, CREO, and simulation tools, including Finite Element Analysis (Abaqus, ANSYS) and SolidWorks Simulation.

Experience in a FDA-regulated environment, including knowledge of ISO 13485 and FDA regulatory requirements.

2.5.2 Additional Qualifications:

Certified SolidWorks Professional Mechanical Design (CSWP).

Experience with machine-based repetitive manufacturing, including automation and controls.

Familiarity with RF welding desirable.

Experience using DFMA methodologies and developing tools/fixtures for process optimization.

Knowledge of controlled environment protocols.

2.6 Skills:

Excellent written and verbal communication skills.

Strong analytical and interpersonal skills.

Ability to lead and motivate team members.

Methodical, organized, and able to manage multiple projects concurrently.

Proficient in MS Office tools, including Word, Excel, Visio, MS Project, Access, and PowerPoint.

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