Principal Manufacturing Engineer

Werfen; Massachusetts; On-site; USD 80,000 - 120,000; Full time

Job summary

An innovative company is seeking a seasoned engineer to lead process engineering and production support for specialized diagnostics. This role involves driving continuous improvement initiatives, providing technical leadership, and optimizing manufacturing processes. With a commitment to healthcare excellence, you'll collaborate with teams to enhance product manufacturability and quality. Join a dynamic environment where your expertise will directly impact patient care and operational efficiency. If you're passionate about engineering and ready for a challenge, this opportunity is perfect for you.

Qualifications

• 15 years of experience in engineering or 10 years with an M.S. degree.
• Experience in technical support for manufacturing of instrumentation preferred.

Responsibilities

• Lead process engineering and production support for product lines.
• Resolve production process issues using problem-solving techniques.

Skills

Problem Solving

Process Improvement

Technical Leadership

Lean Six Sigma

Engineering Principles

Education

B.S. in Engineering

M.S. in Engineering

Tools

Test Equipment

Assembly Equipment

Job description

Job Information

Number

ICIMS-2025-8427

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.

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 asse.
• Responsible for establishing the Manufacturing Quality Plan (MQP) 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; Collaborates 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

Budget Managed (if applicable): N/A

Internal Networking/Key Relationships:

• To be determined based on department needs

Skills & Capabilities:

• Ability to plan and conduct work requiring the application of extensive and diversified knowledge of engineering principles in broad areas of assignments
• Ability to maintain a clear overview of major projects, make sound judgments necessitated by available time and technical capacity to meet set objectives

Qualifications

Min Knowledge & Experience Required for the Position:

• B.S. in Engineering and a minimum of 15 years of experience or an M.S. Degree and a minimum of 10 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 preferable

International Mobility Required: No

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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