Process Automation Engineer

3 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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