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Senior Mechanical Engineer II

Werfen

Bedford, MAOnsitePosted 5 days ago$130,000 - $160,000/year
Full TimeSenior LevelManufacturing & CMCDiagnostics
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Summary

The Senior Mechanical Engineer II 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.

Job description

Position Summary

The Senior Mechanical Engineer II 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 Senior Engineer II 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.

Key Accountabilities

  • 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 leads implementation of improvement initiatives to aid department practices.
  • 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
  • Mentoring

Qualifications

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

Experience: Ten years of product development or relevant experience; Six to eight 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

Travel Requirements: Some domestic and international travel may be required.

Requirements

  • Bachelor's degree in Engineering, Science or a related field
  • Ten years of product development or relevant experience
  • Six to eight years of product development or relevant experience for advanced degrees
  • Proficiency in English language required
  • Parametric CAD modeling (Creo preferred)
  • GD&T and tolerance analysis expertise
  • Medical device quality and regulatory standards experience
  • In vitro medical device experience highly desired

Benefits

  • Medical, Dental & Vision
  • 401(k) Matching
  • Paid Vacation
  • Sick Leave

Company overview

Werfen is a global leader in specialized diagnostics, founded in 1966 in Barcelona, Spain as a family-owned innovative company. The organization has established itself as a worldwide authority in five key clinical areas: Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant diagnostics. With headquarters in Barcelona and technology centers strategically located in the United States and Europe, Werfen operates directly in 30 countries and serves more than 100 territories through distributors. The company achieved remarkable financial performance with worldwide sales exceeding €2.2 billion in 2024, supported by a workforce of over 7,000 employees globally. Werfen's comprehensive portfolio includes advanced diagnostic systems, reagents, laboratory automation solutions, and point-of-care testing platforms that enable healthcare providers to deliver precise and timely patient care. Their innovative technologies span from blood gas analyzers with hemolysis detection capabilities to automated immunoassay systems and specialized diagnostic assays. As a vertically integrated diagnostics company, Werfen maintains complete control over research, development, manufacturing, and distribution, ensuring quality and reliability across their product lines while continuously advancing diagnostic science to address critical healthcare challenges worldwide.

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