Process Engineer III

Werfen; Bedford (MA); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

401k with employer match

Paid vacation and sick leave

Job summary

Werfen in Bedford, Massachusetts is seeking a motivated Process Engineer to join our On-Market Sustaining Engineering team. You will support lifecycle initiatives, drive design improvements, and collaborate with R&D, Manufacturing, and Quality to enhance product reliability.

The role requires root cause analysis, data-driven problem solving, and validation planning across development lifecycles. Annual base salary ranges from $90,000 to $120,000 with comprehensive benefits.

Qualifications

• Bachelor's degree in engineering, science or related field.
• Five years of product development or relevant experience.
• In vitro medical device experience highly desired.
• English language proficiency required.

Responsibilities

• Independently plans, performs & prioritizes tasks that are complex in nature.
• Analyzes data, identifies trends and presents next steps.
• Leads test strategies and validation activities (IQ/OQ/PQ).
• Drives risk management, design requirements and CAPA processes.
• Transit validated processes to operations with training and support.

Skills

Statistical Analysis

Root Cause Analysis

Creative Problem Solving

Leadership

Communication

Education

Bachelor's degree in Engineering, Science or a related field

Job description

Werfen - 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:

We are seeking a motivated and detail-oriented Process Engineer to join our On-Market Sustaining Engineering team. In this role, you will support both proactive and reactive product lifecycle initiatives, driving design enhancements, process improvements, and product reliability efforts. The ideal candidate is analytical, methodical, and collaborative, with the ability to thrive in a fast-paced, cross-functional environment. Working within established engineering procedures, you will contribute to reliability and continuous improvement projects while partnering closely with R&D, Manufacturing, and Quality teams.

Under the guidance of senior engineering personnel, you will be responsible for conducting root cause investigations, collecting and analyzing data, developing and implementing corrective solutions, and supporting validation activities. Key focus areas include data analysis and presentation, problem-solving, validation protocol development and execution, and driving sustainable improvements to products and manufacturing processes throughout the product lifecycle.

The annual base salary range for this role is currently $90,000 to $120,000. Individual employee compensation will ultimately depend on factors including education, relevant experience, skillset, knowledge, and particular business needs.

This role is eligible for medical, dental, and vision insurance, 401k plan retirement benefits with an employer match, as well as paid vacation and sick leave.

Responsibilities

Key Accountabilities

Essential Functions:

• Acts as an Individual contributor, core team or technical lead for a specific project or product line.
• Accountable for the completion of assigned deliverables in accordance with approved schedules.
• Authors documentation and participates in activities in support of design control.
• Independently plans, performs & prioritizes tasks that are complex in nature, in alignment with corporate goals.
• Analyzes and interprets data, identifying trends and formulating next steps
• Ability to present tradeoff analysis and provide sound recommendations based on technical assessment.
• Experience leading the development of test strategies, execution process validation, including: IQ, OQ, PQ, Guage R&R, DoE, process capability.
• Must have experience in design requirements and risk management (pFMEA), driving risk mitigation to closure in collaboration with cross-functional teams.
• Experience working with electromechanical assemblies and instrumentation and test fixtures.
• Effectively communicates technical information to a multidisciplinary team in the form of documentation, presentations and technical summaries and promotes collaboration.
• Independently generates predictable schedules for activities related to the function, understanding cross-functional dependencies.
• Responsible for estimating and planning validation activities across the development lifecycle
• Transition validated process to operations: provide training, procedures, and on-floor support

Secondary Functions:

• May review and provide input to deliverables from other functions.
• Recommends and drives improvement initiatives and motivates others to implement.
• May be assigned CAPA ownership.

Internal Networking/Key Relationships

To be determined based on department needs, to include interactions such as:

• Will interface on a regular basis with groups across the organization as needed

Skills & Capabilities:

• Statistical Analysis, Root Cause Analysis, Creative Problem Solving
• Technically adept and confident
• Leadership: Accountability, Decision Making, Communication

Qualifications

Minimum Knowledge & Experience Required for the Position:

Education:

• Bachelor's degree in Engineering, Science or a related field

Experience:

• Five years of product development or relevant experience
• One to three years of product development or relevant experience for advanced degrees
• For internal candidate promotion: Demonstrated proficiency in meeting all competencies of current level and acceptable performance history may be used in lieu of experience
• In vitro medical device experience highly desired.

Additional Skills/Knowledge:

• Language: Proficiency in English language required

International Mobility:

• Required: No

Travel Requirements:

• Some domestic and international travel may be required.

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.