Principal Mechanical Engineer, R&D

Werfenlife SA.; Bedford (MA); On-site; USD 150,000 - 185,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401k plan with employer match

Paid vacation

Paid sick leave

Job summary

Werfenlife SA. is seeking a Principal Mechanical Engineer in Bedford, Massachusetts to lead the design, development, and integration of complex electromechanical systems for medical diagnostic products. The role requires at least twelve years of relevant experience and offers a salary range of $150,000 to $185,000 based on qualifications and experience.

This position involves working collaboratively across product development stages and providing technical leadership while ensuring compliance with medical device standards. Benefits include medical, dental, vision insurance, and 401k plan.

Qualifications

• Twelve years of product development or relevant experience.
• In vitro medical device experience highly desired.
• Proficiency in English language required.

Responsibilities

• Lead the design and development of complex electromechanical systems.
• Create manufacturable designs ensuring compliance with medical device standards.
• Collaborate with cross-functional teams throughout product development lifecycle.

Skills

Statistical Analysis

Root Cause Analysis

Creative Problem Solving

Critical Thinking

Education

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

Tools

Creo

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:

The Principal Mechanical Engineer leads the design, development, and integration of complex electromechanical systems for medical diagnostic and IVD products, including motion systems, precision fluidics, and thermal management solutions. This role applies advanced engineering principles, parametric CAD modeling (Creo preferred), simulation tools, and deep expertise in GD&T, tolerance analysis, and complex assemblies to deliver robust, manufacturable designs. Responsible for translating product requirements into system architecture and mechanical solutions, the engineer makes sound design trade-offs balancing performance, cost, manufacturability, and time-to-market while ensuring compliance with medical device quality and regulatory standards.

This position requires broad ownership across the product development lifecycle -from concept through verification, validation, and design transfer - while collaborating closely with cross-functional teams to drive technical decisions and product success. The Principal Engineer brings strong experience in designing for a range of manufacturing processes and large-scale systems, contributes to product architecture decisions informed by customer and marketing inputs, and provides technical leadership by guiding project direction, influencing engineering practices, and mentoring junior engineers.

The annual base salary range for this role is currently $150,000 to $185,000. 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 the next steps, while effectively performing trade off analysis, if required by the function.
• Leads, designs and/or develops one or more of the following: new test methods, specifications, technical apparatus, software and processes for complex components and functions.
• Evaluates complex designs or processes, with respect to acceptability, suitability and cost. Recommends preferred design options. Presents trade-off, if required by the function.
• Identifies product defects and able to recognize outliers in results. Able to explain and document product defects and their impact.
• Effectively communicates technical information to a multidisciplinary team in the form of documentation, presentations and technical summaries and promotes collaboration.
• Technical expertise in more than one or a subject matter expert in at least 1 area.
• Leads without authority & provides technical guidance to engineers and technicians assigned to him/her on a given project. Provides mentoring within or outside of their department.
• Provides technical support for or leads CAPA or complaint investigations.
• Independently generates predictable schedules for activities related to the function, understanding cross-functional dependencies.

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.

Skills & Capabilities:

• Statistical Analysis (if required by the function), Root Cause Analysis, Creative Problem Solving, Critical Thinking
• Technically adept and confident
• Leadership: Accountability, Decision Making, Influence, Communication

Qualifications

Minimum Knowledge & Experience Required for the Position:

Education:

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

Experience:

• Twelve years of product development or relevant experience
• Eight plus 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.