Senior Manufacturing Engineer II

Werfen; Bedford (AL); On-site; USD 120,000 - 180,000; Full time

Job summary

Werfen is seeking a Senior Manufacturing Engineer II (Production Transfer Specialist) to drive successful transfer of production lines. You will bridge advanced process engineering with project management, documenting methods, managing timelines, and ensuring zero disruption to quality or supply. The role requires global collaboration and international travel.

Candidates should have 12+ years with a B.S. in Engineering or 8+ years with an M.S., plus Lean Six Sigma expertise and experience in

Qualifications

• B.S. in Engineering and 12+ years of experience or M.S. with 8+ years.
• Experience in manufacturing instrumentation or disposables preferred.
• Lean Six Sigma problem solving experience preferred.

Responsibilities

• Resolve production process issues using root-cause analysis and corrective actions.
• Deliver long-term cross-functional projects on time and budget.
• Lead or participate in process engineering and manufacturing support for product lines.
• Provide technical leadership for continuous improvement in manufacturability.
• Develop and implement assembly/test methods and process optimization.
• Establish Manufacturing Quality Plans and associated documentation.

Skills

Problem solving

Process engineering

Project management

Lean Six Sigma

Education

B.S. in Engineering

M.S. Degree

Tools

IQ/OQ/PQ validation

Job description

Introduction

Werfen

Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized assays and biomaterials. We operate directly in 30 countries, and in more than 100 territories through distributors. Our Headquarters and Technology Centers are located in the US and Europe, and our workforce is more than 7,000 strong.

Our success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality. We’re passionate about providing healthcare professionals the most valuable and complete solutions to improve hospital efficiency and enhance patient care.

Overview

Position Summary

As a Senior Manufacturing Engineer II (Production Transfer Specialist), you will play a pivotal role in executing manufacturing strategy by driving the successful transfer of production lines. This role bridges the gap between deep technical process engineering and rigorous project management. You will be responsible for deeply understanding our current production processes, continuous improvements/optimization, documenting methodologies, managing timelines, and ensuring a seamless transition with zero disruption to quality or supply. Because this is a highly collaborative global role, success requires a flexible schedule to accommodate early morning or evening calls with international teams, alongside the ability to travel internationally.

Responsibilities

Key Accountabilities:

• Responsible for the resolution of production process issues utilizing problem solving techniques to analyze, identify root cause(s), develop and implement solutions
• Responsible for delivering long‑term cross functional impactful projects on time and on budget
• May be required to act as Product Champion for a specific product or product line with the following leadership responsibilities
  • The focal point in operations for the products which they have responsibility for.
  • Leads the resolution of production process issues utilizing problem solving techniques to analyze, identify root cause(s), develop and implement solutions.
  • Leads the process engineering and production support activities required for the manufacture of a product line.
  • Provides technical support and leadership for continuous improvement team efforts focused on process improvement and improvements to product manufacturability.
  • Provides technical leadership and hands‑on engineering support, including specification and implementation of assembly/test methods and process optimization.
• Provides technical support for continuous improvement efforts conducting root cause analysis then formulating and implementing corrective action proposals
• Responsible for establishing the Manufacturing Quality Plan (MOP) for a product or product line including process flow, production floor layout, equipment, line balancing, etc.
• Writes process procedures, change orders, equipment specifications, validation plans, and reports
• Performs research on technology, equipment, and tooling to improve process quality, yield, or cost; Generates proposals for purchase and implementation, including cost of ownership, ROI and benefit analysis
• Performs engineering design of test equipment, assembly equipment, fixtures, and tools; Performs IQ/OQ/PQ validation activities
• Participates in the introduction of new products into manufacturing; Collaborate with R&D and suppliers to improve product robustness and manufacturability both pre‑ and post release
• Supervises (as assigned) personnel in classifications below that of Senior Mfg. Engineer
• May lead or participate in Lean Six Sigma projects of significant scope and complexity

Internal Networking/Key Relationships

To be determined based on department needs

Qualifications

Minimum Knowledge & Experience required for the position:

• B.S. in Engineering and a minimum of 12 years of experience or an M.S. Degree and at least 8 years of experience
• Experience in technical support for the manufacturing of instrumentation and/or disposables preferred
• Experience in Lean and Six Sigma problem solving methodologies preferred

Skills & Capabilities:

• Functional/technical skills

Travel Requirements:

• <5% of time

Werfen is an Equal Opportunity employer and is committed to a diverse workplace. Werfen strictly prohibits unlawful discrimination, harassment or retaliation based upon an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other protected characteristic as defined by applicable state or federal law. If you have a disability and need an accommodation in relation to the online application process, please contact [e-mail] for assistance.

We operate directly in over 30 countries, and in more than 100 territories through distributors. Annual revenue is approximately $2 billion and more than 7,000 employees around the world comprise our Werfen team.

www.werfen.com