Avna Jobs in Usa

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.

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 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/Crewfactor)
• 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 and 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.
• Scrap Rate: Pieces Scrapped / Pieces Produced
• 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.

Continuous Improvement

• 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.

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) 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.
• Capable of working with minimal or no supervision.
• A can-do attitude.

Position:

The Engineering Project Manager will report directly to the PMO Manager and will be responsible for leading and managing assigned NPI Projects from project initiation through production hand-off.

Key Goals:

The EPM goal when managing projects is to meet or exceed internal and external customer expectations while maintaining the scope, quality and any costs associated with the project. The Engineering Project Manager will oversee and manage the activities of multiple projects involving contracted component/assembly processes, equipment/tooling builds, and plant layout tasks that support all three AVNA facilities.

Responsibilities:

• The EPM will facilitate communication between the customer and the internal project team. The EPM will guide contractual conversations, technical conversations, and production conversations.
• The EPM manages activities for cross-functional team members that include Manufacturing Engineers, Quality Engineers, Automation Engineers, Toolmakers/technicians, Maintenance, product supervisors, estimating/quoting/sales, Buyers/Planners, outside vendors, etc.
• Develops and maintains multi-phase project plans and timelines while adhering to scope, quality and project costs. Any milestone dates, risks, or failures must be clearly communicated to the customer in a timely manner.
• Identifies project risks and addresses accordingly during all stages of the project. The EPM must understand the use of technical and financial information from past projects and the experience of subject matter experts.
• The EPM will collaborate with a multi-functional team to resolve technical challenges. The EPM will assist with troubleshooting, data analysis and in-depth evaluation of the process, equipment or tooling when needed.
• Oversees all project operation rate variants as it relates to gross profit margins. The EPM alters/improves processes with the technical lead during the NPI stage as it relates to cost, efficiency or quality.
• Works with outside suppliers to develop or confirm material, component or assembly processes.
• Works with outside vendors for gages, tooling, equipment or services that are required within the project plan or capital expense.
• Technical writing will be owned by the EPM such as IQ/OQ/PQ protocols and reports. The EPM must ensure other technical documents are correctly completed during the specified project phase per any phase gates.
• Convey meeting minutes with specific actions/timing for all internal and external meetings that are led by the EPM.

Requirements:

• 5+ years of project management experience as an engineer or project manager, preferably in the medical device industry.
• Hands-on technical support in the Berlin, CT facility and New Britain, CT facility is required.
• Formal project management training (PMP certified) is preferred.
• Skilled in a project management software product (Smartsheet preferred)
• Engineering skills or technical skills surrounding manufacturing: Tooling design, metal stamping/milling/turning/grinding, injection molding, laser processing, assembly processes.
• Skilled in a 3D CAD software (Solidworks preferred) and 2D CAD software (AutoCAD or Draftsite preferred).
• Experience with PPAP (production part approval process) is preferred.
• Must be able to interpret technical drawings, product requirements and design specifications.
• Understanding of lean manufacturing/six sigma and trained in a statistical software for MSAs and Capability studies (green belt certification and Minitab preferred, respectively)
• Outstanding verbal and written communication skills for different cross-function team members and customer interface.
• Ability to self-educate and learn new processes
• ISO13845 experience is recommended