Process Development Engineer II

Werfenlife SA.; Bedford, Northern (MA, KY); Hybrid; USD 80,000 - 100,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401k with employer match

Paid vacation

Job summary

Werfen is seeking an engineer to support process development, validation, and platform initiatives in Bedford, MA. You will plan and execute IQ/OQ/PQ studies, analyze data, and collaborate with cross-functional teams to implement new designs and technologies.

With a BS in Engineering and at least 2 years of related experience, you will contribute to continuous improvement while ensuring compliance with quality and regulatory requirements. The role is on-site in Massachusetts.

Qualifications

• B.S. in Engineering and at least 2 years of related experience or equivalent education/experience.
• Experience with validation under IQ/OQ/PQ and process qualification.
• Ability to perform characterization studies and data analysis.

Responsibilities

• Perform validation activities including IQ, OQ, PQ and evaluate operating conditions.
• Review risk documents such as pFMEAs and support risk analysis.
• Carry out varied engineering assignments with limited supervision and guidance.
• Provide technical direction to support personnel as directed by supervisor.
• Design and develop moderately complex parts, components, or circuits.
• Prepare specifications for developed parts and circuits.
• Maintain engineering notebooks and document results clearly.
• Collaborate with cross-functional teams to support new designs and platform tech.

Skills

Validation activities

IQ/OQ/PQ

Process characterization

Engineering analysis

Education

B.S. in Engineering

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:

Using company procedures, quality system requirements, and engineering best practices, performs process development, characterization, and validation activities in support of new product introduction (NPI) and platform-based initiatives. Independently plans and executes process characterization studies, process optimization efforts, and qualification protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). Analyzes process data to identify trends, assess process capability, and drive continuous improvement. Collaborates with cross-functional teams to support the development and implementation of new designs and platform technologies as identified by program leadership. Operates with a high degree of technical judgment and autonomy while ensuring compliance with applicable quality and regulatory requirements.

Responsibilities

• Ability to perform validation activities, including but not limited to Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and evaluation of process operating conditions.
• Ability to perform validation activities, including but not limited to understanding risk documents such as pFMEAs.
• Performs varied engineering assignments under minimum of direct supervision and technical guidance.
• Technical responsibilities directed to engineering assignments which substantially add to the program.
• Designs and develops moderately complex parts, components, and/or circuits.
• Provides technical direction to support personnel as directed by engineering supervisor.
• Accomplishes independent designs, analyses, and interpretations of engineering data.
• May test materials for adherence to technical specifications.
• Prepares specifications for developed parts, components, and/or circuits.
• Maintains a good engineering notebook.
• Provides limited technical guidance to other engineers and supervision to technicians assigned to projects.
• Performs other duties as requested

Qualifications

Min Knowledge & Experience required for the position:

• B.S. in Engineering and a minimum of 2 years experience related to the areas given above or suitable equivalent combination of education and experience.

International Mobility: Required: no

• <5% of time

The annual base salary range for this role is currently $80K to $100K. 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.Our sales roles are eligible for participation in a commission plan and our management,and select professional roles,are eligible for a performance-based bonus.

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.