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Werfen

Global specialized diagnostics provider

Senior Mechanical Engineer 2

Design EngineeringConfirmed live in the last 24 hours
Full-timeBedford, MA, USA

About the Job

Requirements

  • A bachelor's degree in Engineering, Science, or a related field is required.
  • Ten years of product development or relevant experience is required; candidates with advanced degrees may qualify with six to eight years of product development or relevant experience.
  • Proficiency in English is required.
  • The role requires technical expertise in more than one area or subject-matter expertise in at least one area.
  • Skills include statistical analysis when required by the function, root cause analysis, creative problem solving, and critical thinking.

Responsibilities

  • Act as an individual contributor, core team member, or technical lead for a specific project or product line.
  • Complete assigned deliverables in accordance with approved schedules.
  • Author documentation and participate in activities supporting design control.
  • Independently plan, perform, and prioritize complex tasks in alignment with corporate goals.
  • Analyze and interpret data, identify trends, formulate next steps, and perform trade-off analysis when required.
  • Lead, design, and/or develop new test methods, specifications, technical apparatus, software, and processes for complex components and functions.
  • Evaluate complex designs or processes for acceptability, suitability, and cost; recommend preferred design options and present trade-offs when required.
  • Identify product defects and outliers in results, and explain and document defects and their impact.
  • Communicate technical information to multidisciplinary teams through documentation, presentations, and technical summaries, and promote collaboration.
  • Provide technical guidance to engineers and technicians assigned to a project and mentor colleagues within or outside the department.
  • Provide technical support for or lead CAPA or complaint investigations.
  • Generate predictable schedules for functional activities while accounting for cross-functional dependencies.
  • Review and provide input on deliverables from other functions when assigned.
  • Recommend and lead implementation of initiatives to improve department practices.
  • Take ownership of CAPA when assigned.
  • Lead design, development, and integration of complex electromechanical systems for medical diagnostic and IVD products, including motion systems, precision fluidics, and thermal management solutions.
  • Apply engineering principles, parametric CAD modeling, simulation tools, GD&T, tolerance analysis, and complex assembly methods to develop robust, manufacturable designs.
  • Translate product requirements into system architecture and mechanical solutions, making design trade-offs among performance, cost, manufacturability, and time-to-market while ensuring compliance with medical-device quality and regulatory standards.
  • Own work across the product development lifecycle from concept through verification, validation, and design transfer, collaborating with cross-functional teams to drive technical decisions and product success.
  • Design for a range of manufacturing processes and large-scale systems, contribute to product architecture decisions informed by customer and marketing inputs, and guide project direction and engineering practices.

Desired Qualifications

  • In vitro medical device experience is highly desired.
  • Creo is preferred.

About the Company

Werfen

Global specialized diagnostics provider

Werfen focuses on in vitro diagnostics, offering specialized diagnostic solutions for healthcare. It provides tests and instruments for areas like hemostasis (blood clotting), acute care diagnostics, and autoimmunity, used by clinical laboratories to detect and monitor diseases. The company's products combine diagnostic assays, reagents, and instrumentation that run in laboratory workflows to produce actionable patient results. Werfen differentiates itself through its long-standing family-owned heritage, strategic growth including the 1991 acquisition of Instrumentation Laboratory, and a global footprint that spans 30 countries with active presence in more than 100 territories. The goal is to improve patient care by expanding access to accurate, high-quality diagnostic tools and services while maintaining a strong commitment to quality and specialized solutions.

Company size
1,001-5,000
Company stage
Debt Financing
Total funding
$550M
Headquarters
Barcelona, Spain
Founded
1966

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