Manufacturing Engineer (medical devices)

Impact Partners Group; Berlin (CT); On-site; USD 70,000 - 90,000; Full time

Job summary

Impact Partners Group is hiring a Manufacturing Engineer in Berlin, CT. The role focuses on optimizing processes, ensuring safety and quality standards are met, and collaborating with various teams for continuous improvement.

The ideal candidate has a degree in Manufacturing Engineering, along with relevant experience, problem-solving, and communication skills. Proficiency in CAD software and ERP systems is essential. This role requires onsite presence 4-5 days a week.

Qualifications

• Bachelor’s degree in Manufacturing, Mechanical, or Industrial Engineering.
• 3–7 years in a manufacturing environment preferred.
• Experience with Lean and Six Sigma practices.

Responsibilities

• Optimize process capability of the product group.
• Collaborate with teams for process control best practices.
• Provide technical guidance during equipment installation.

Skills

Manufacturing processes knowledge

Lean manufacturing

Six Sigma

Problem-solving abilities

Communication skills

Education

Bachelor’s degree in Engineering

Tools

SolidWorks

AutoCAD

ERP systems

Job description

Location: Onsite 4-5 days in Berlin, CT

Position Summary

The Manufacturing Engineer is responsible for optimizing the process capability of the assigned product group by developing and verifying processes, analyzing process flows, implementing performance improvements, and conducting long-term process monitoring. This role ensures that production operations meet safety, quality, cost, and delivery objectives through process improvements, technical support, and continuous improvement initiatives. The engineer acts as the technical liaison between design, production, quality, and maintenance teams to sustain and enhance product line performance.

Qualifications

• Education: Bachelor’s degree in Manufacturing Engineering, Mechanical Engineering, Industrial Engineering, or a related field.
• Experience: 3–7 years of experience in a manufacturing environment; experience supporting a dedicated product line is preferred.
• Capable of meeting and exceeding timelines.
• Strong knowledge of manufacturing processes, equipment, and production systems.
• Experience with Lean manufacturing, Six Sigma, and root cause analysis tools (e.g., 5 Whys, Fishbone Diagram, FMEA).
• Proficiency with CAD software (SolidWorks, AutoCAD) and ERP systems.
• Understanding of GD&T, process capability (Cp, Cpk), and statistical process control (SPC).
• Strong analytical and problem-solving abilities.
• Excellent communication and collaboration skills.
• Ability to manage multiple projects and priorities in a fast-paced environment.

Key Responsibilities

Safety & Compliance

• Ensure compliance with safety, environmental, and regulatory standards in all process designs and implementations.

Quality

• Collaborate with Quality Assurance and implement best practices for process control.

Daily Operations

• Ensure stable and efficient production processes to support execution of the production plan.
• Train operators and supervisors on new processes, equipment, and quality standards.
• Provide technical guidance during equipment installation, qualification, and maintenance troubleshooting.

Process Standards

• Update and maintain production standards in ERP (Standard Rates/Crew factor).
• Develop, document, and maintain manufacturing process instructions, standard work, and operating procedures.

Process Improvement

• Collaborate with Quality and Production teams to reduce setup times, improve cycle times, and reduce scrap.
• Analyze production data to identify trends, inefficiencies, and opportunities for cost reduction and process improvement.
• Design and validate tooling, fixtures, and process layouts to ensure ergonomic and efficient operations.
• Monitor and improve key performance indicators (KPIs) such as throughput, downtime, and quality metrics.
• Participate in cross-functional continuous improvement activities, including Lean, 5S, and Six Sigma initiatives.

Problem Solving

• Actively participate in root cause analysis and corrective/preventive actions (CAPA) for process-related issues, internal rejections, and customer complaints.

Communication

• Foster open, cross-functional communication across all levels and departments to address opportunities and challenges within the product line.
• Support new product introductions (NPI) and engineering change implementations within the product line.

Key Metrics (Product Line Performance Card)

Safety and Compliance

• Recordable Incident Rate: OSHA-reportable safety incidents per period.
• Near Miss Reporting: Frequency of safety risks reported before they become incidents.

Quality

• Customer complaints and/or returns: Frequency and type of product issues reported post-shipment.
• Internal Rejections/Defect Rate: Issues found during process control checks.

Production Performance

• On-Time Delivery (OTD).
• Production Efficiency: Actual output vs. planned output.
• GMP (Good Manufacturing Practices).

Cost Control

• Product Line GPM Targets (Gross Profit Margin).
• Material Usage Variance: Difference between actual and expected material usage.
• Kaizen Participation: Employee involvement in improvement activities.
• Downtime Analysis: Root cause tracking and reduction of unscheduled downtime.
• 5S or Visual Management Audits: Scores from housekeeping and organization assessments.

Willingness to stay current with emerging technologies is vital.