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Lead Manufacturing Engineer III

2 months ago

Bedford Massachusetts, United States Werfen Full time

Overview:
Werfen

Werfen is a dynamic, family-owned enterprise established in 1966 in Barcelona, Spain.

We are a global frontrunner in specialized diagnostics, focusing on Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplantation.

Through our Original Equipment Manufacturing (OEM) division, we engage in the research, development, and production of tailored assays and biomaterials. We have a direct presence in 30 countries and operate in over 100 territories through distributors.

Our Headquarters and Technology Centers are strategically located in the US and Europe, employing a workforce of more than 7,000 dedicated professionals.


Our achievements stem from a concentrated focus on these rapidly advancing diagnostic fields, our unwavering commitment to our clients, and our passion for innovation and quality.

We are dedicated to equipping healthcare professionals with the most effective and comprehensive solutions to enhance hospital efficiency and improve patient care.

Position Summary

In this role, you will be accountable for spearheading the process engineering and production support for a specific product or product line. You will provide technical guidance and support for continuous improvement initiatives aimed at optimizing processes.

Your responsibilities will include engineering leadership for the design, documentation, and execution of assembly methods, testing procedures, and equipment operations, including their specification and optimization.


Responsibilities:

Key Accountabilities:
• Address production process challenges by employing problem-solving techniques to analyze and identify root causes, and develop and implement effective solutions.

• Ensure the timely and budget-conscious delivery of impactful, long-term cross-functional projects.


• May serve as the Product Champion for a designated product or product line, acting as the primary contact in operations for those products.


• Lead efforts to resolve production process challenges using analytical techniques to identify root causes and implement solutions.

• Oversee the process engineering and production support activities necessary for the manufacturing of a product line.

• Provide technical support and leadership for continuous improvement initiatives aimed at enhancing process efficiency and product manufacturability.

• Deliver hands-on engineering support, including the specification and implementation of assembly and testing methods, along with process optimization.

• Conduct root cause analyses for continuous improvement efforts and formulate corrective action proposals.


• Establish the Manufacturing Quality Plan (MQP) for a product or product line, which includes process flow, production floor layout, equipment, and line balancing.

• Draft process procedures, change orders, equipment specifications, validation plans, and reports.

• Research technology, equipment, and tooling to enhance process quality, yield, or cost; generate proposals for acquisition and implementation, including cost of ownership, ROI, and benefit analysis.

• Design test equipment, assembly equipment, fixtures, and tools; conduct IQ/OQ/PQ validation activities.

• Participate in the introduction of new products into manufacturing; collaborate with R&D and suppliers to enhance product robustness and manufacturability both pre- and post-launch.

• Supervise personnel in classifications below that of Senior Manufacturing Engineer as assigned.

• May lead or participate in Lean Six Sigma projects of significant scope and complexity.

Budget Managed (if applicable)

N/A

Internal Networking/Key Relationships

To be determined based on departmental needs.

Skills & Capabilities:
• Strong functional and technical skills.

Qualifications:

Minimum Knowledge & Experience required for the position:
• B.S. in Engineering with a minimum of 12 years of experience, or an M.S. Degree with at least 8 years of experience.

• Preferred experience in technical support for the manufacturing of instrumentation and/or disposables.

• Familiarity with Lean and Six Sigma problem-solving methodologies is preferred.

International Mobility:

Required:
No

Travel Requirements: