Senior Manufacturing Engineer II

Werfen; Massachusetts; On-site; USD 90,000 - 120,000; Full time

Job summary

A leading company in specialized diagnostics is seeking a Process Engineer to oversee production processes and lead continuous improvement initiatives. The ideal candidate will have extensive engineering experience and a strong background in Lean and Six Sigma methodologies. This role involves technical leadership, problem-solving, and collaboration with cross-functional teams to optimize manufacturing efficiency and product quality.

Qualifications

• Minimum 12 years experience with B.S. or 8 years with M.S. in Engineering.
• Experience in Lean and Six Sigma preferred.

Responsibilities

• Lead process engineering and production support for product lines.
• Resolve production process issues and implement solutions.
• Establish Manufacturing Quality Plan for products.

Skills

Functional/technical skills

Education

B.S. in Engineering

M.S. Degree

Job description

Job Information

Number

ICIMS-2025-8826

Job function

Manufacturing

Job type

Full-time

Location

Bedford - 180 Hartwell Road Bedford, Massachusetts 01730 United States

Country

United States

Shift

1st

About the Position

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

Responsible for leading the process engineering and production support of a product or product line. Provides technical leadership and support for continuous improvement team efforts focused on process improvement and optimization. Provides engineering leadership for the design, documentation and implementation of assembly methods, test methods, equipment operation, including specification and optimization.

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

If you are interested in constantly learning and being challenged on a daily basis we encourage you to submit your resume or CV.

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

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