Manufacturing Process Engineer - Arcmed : Job Details

Our Strategy and Purpose

• We provide technology and supply chain solutions for the design and manufacture of precise fluid handling components for diagnostic and analytical instruments.
• We improve patient outcomes and help engineers, scientists, and doctors to solve the world's toughest diagnostic and analytical challenges.
• We always act with intention and drive to achieve our purpose.
• Teamwork, collaboration, and diverse opinions make us stronger.
• We are unafraid to make timely decisions, and we empower our people to make decisions, execute them and move forward.
• We value people and take the initiative and hold themselves accountable.
• Challenging the status quo helps us grow. Look for and call out improvements.

About Arcmed

Simplifying the Design and Build of Diagnostic and Analytical Instruments. Arcmed helps solve the world's toughest diagnostic and analytical challenges. We simplify the design and build of top-performing instruments that exceed your fluidics quality and performance requirements.

Job Summary

The Process Engineer will play a critical role in optimizing our manufacturing processes to improve efficiency, reduce costs, and enhance product quality. This is a hands-on position that requires a strong presence on the manufacturing floor to identify bottlenecks, troubleshoot issues, and implement practical solutions. The ideal candidate is a problem-solver who can apply a solid engineering foundation to real-world manufacturing challenges, who can balance the need for speed with the absolute requirement for quality and compliance.

**Travel required between sites in CT and NJ**

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Process Improvement & Optimization:
• Design, develop, and implement new manufacturing processes and optimize existing ones to improve productivity, reduce waste, and minimize costs.
• Conduct detailed analysis of current workflows, equipment, and production data to identify areas for improvement.
• Apply Lean Manufacturing, Six Sigma, and other continuous improvement methodologies to drive operational excellence.
• Automation & Equipment:
• Identify opportunities for automation and collaborate with cross-functional teams to design, justify, and implement new automation solutions.
• Select, test, and source new equipment and tooling, ensuring they meet production requirements and safety standards.
• Troubleshoot and resolve process-related issues on the manufacturing floor to minimize downtime and maintain production flow.
• Documentation & Standards:
• Create and maintain comprehensive process documentation, including standard operating procedures (SOPs), work instructions, and process flow diagrams.
• Ensure all processes and changes comply with quality management systems (e.g., ISO 9001), safety standards, and other regulatory requirements.
• Process Development & Design Transfer:
• Develop and implement new manufacturing processes for a broad range of IVD products, ensuring they meet specified quality, cost, and timeline requirements.
• Lead the design transfer process for new products, ensuring a smooth and compliant transition from R&D to full-scale manufacturing.
• Validation & Documentation:
• Develop and execute validation protocols (IQ, OQ, PQ) to qualify and validate manufacturing processes and equipment.
• Generate and maintain comprehensive documentation, including Design History Files (DHF), Device Master Records (DMR), and process validation reports to support regulatory submissions and audits.
• Standards & Regulatory Compliance:
• Ensure all processes and changes comply with quality management systems such as ISO 9001
• Actively participate in internal and external audits by providing technical expertise and supporting documentation.
• Continuous Improvement:
• Apply Lean Manufacturing, Six Sigma, and other continuous improvement methodologies to optimize existing processes, reduce waste, and improve yields in a regulated environment.
• Collaboration:
• Partner with internal teams (Quality Assurance, Regulatory Affairs, R&D) and external customers to understand product specifications and ensure seamless project execution.
• Troubleshooting:
• Act as the primary technical resource for manufacturing, quickly troubleshooting and resolving process-related issues to minimize downtime and maintain production schedules for all active projects.
• Work as directed by Manager.

EDUCATIONAL REQUIREMENTS, QUALIFICIATIONS, and TRAININGS

• Bachelor's degree in manufacturing engineering, Mechanical engineering, Industrial engineering or a related technical field.
• 5+ years of hands-on experience in a regulated manufacturing environment, with direct experience in the medical device or IVD industry.
• Demonstrated experience with process improvement methodologies such as Lean Manufacturing and Six Sigma.
• Strong analytical and problem-solving skills with the ability to identify root causes and implement effective corrective actions.
• Proficiency with process mapping and data analysis tools.
• Excellent communication skills, both verbal and written, with the ability to collaborate effectively with all levels of the organization, from production floor to management.

Preferred Qualifications:

• Experience with automation and robotics in a manufacturing context.
• Experience with specific software, e.g., CAD, SolidWorks, ERP systems].
• Certification in Lean, Six Sigma, or other relevant methodologies.
• Experience working with industry standards, e.g., ISO 9001.
• Experience in contract manufacturing or job shop setting.
• Experience working with a diverse range of materials and manufacturing technologies.
• Experience with injection molding and automated assembly.
• Knowledge of risk management standards, such as ISO 14971.

COMPUTER AND SOFTWARE REQUIREMENTS

• Experience with Epicor a plus.
• Microsoft: Office 365; SharePoint; Teams; Visio; and OneNote preferred.
• Working knowledge of UKG-UltiPro and Workday a plus.
• Ability to operate media equipment such as tablets, smartphones, and other electronic equipment.
• Ability to work with general office equipment.
• Ability to work with and understand databases a must and the ability to learn technical skills.

The qualifications, physical demands, and work environment described herein are representative of those an employee will encounter and must meet to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The requirements listed in this document are the minimum levels of knowledge, skills, or abilities.

Arcmed is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.

This document does not create an employment contract, implied or otherwise, other than an at will relationship.

The above noted job description is not intended to describe, in detail, the variety of tasks that may be assigned but rather to give the incumbent a general sense of the responsibilities and expectations of his/her position. As the nature of business demands change, so, too, may the essential functions of this position.

#Arcmed