Senior Mechanical Engineer II

Werfen•Bedford, MA
•$130,000 - $160,000

About The Position

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. The role applies advanced engineering principles, parametric CAD modeling (Creo preferred), simulation tools, and expertise in GD&T, tolerance analysis, and complex assemblies to deliver robust, manufacturable designs. The engineer translates product requirements into system architecture and mechanical solutions, making design trade-offs that balance performance, cost, manufacturability, and time-to-market while ensuring compliance with medical device quality and regulatory standards. The position has broad ownership across the product development lifecycle, from concept through verification, validation, and design transfer, and collaborates with cross-functional teams to guide technical decisions and product success. The Senior Engineer II brings experience 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. This is an individual-contributor role that may also serve as a core team member or technical lead for a project or product line. It includes authoring design-control documentation, independently planning and prioritizing complex work, evaluating designs and processes, identifying and documenting product defects, supporting CAPA and complaint investigations, and communicating technical information to multidisciplinary teams. Some domestic and international travel may be required. The annual base salary range is $130,000 to $160,000. The role is eligible for medical, dental, and vision insurance, a 401(k) retirement plan with employer match, and paid vacation and sick leave.

Requirements

  • Bachelor's degree in Engineering, Science, or a related field.
  • Ten years of product development or relevant experience; six to eight years for candidates with advanced degrees.
  • For internal promotion candidates, demonstrated proficiency in all competencies of the current level and an acceptable performance history may be used in lieu of the experience requirement.
  • Proficiency in English is required.
  • Expertise in parametric CAD modeling, with Creo preferred; simulation tools; GD&T; tolerance analysis; and complex assemblies.
  • Experience designing complex electromechanical systems for medical diagnostic and IVD products, including motion systems, precision fluidics, or thermal management solutions.
  • Ability to translate product requirements into system architecture and mechanical solutions, balancing performance, cost, manufacturability, and time-to-market.
  • Experience across the product development lifecycle, including concept, verification, validation, and design transfer.
  • Experience designing for a range of manufacturing processes and large-scale systems.
  • Skills in statistical analysis when required, root cause analysis, creative problem solving, and critical thinking.
  • Leadership capabilities including accountability, decision-making, influence, and communication.
  • Ability to provide technical guidance and mentoring.
  • Ability to analyze data, perform design trade-off analysis, communicate technical information, and work collaboratively across disciplines.

Nice To Haves

  • In vitro medical device experience is highly desired.
  • Experience with Creo parametric CAD modeling is preferred.

Responsibilities

  • Serve as an individual contributor, core team member, or technical lead for a specific project or product line.
  • Complete assigned deliverables according to 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, 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 on assigned projects and mentor colleagues within or outside the department.
  • Provide technical support for, or lead, CAPA or complaint investigations.
  • Independently generate predictable schedules for functional activities while understanding cross-functional dependencies.
  • Review and provide input on deliverables from other functions as needed.
  • Recommend and lead implementation of initiatives to improve department practices.
  • May be assigned CAPA ownership.
  • Collaborate with cross-functional teams throughout product development, from concept through verification, validation, and design transfer.
  • Contribute to product architecture decisions using customer and marketing inputs, and guide project direction and engineering practices.

Benefits

  • Medical insurance
  • Dental insurance
  • Vision insurance
  • 401(k) retirement plan with employer match
  • Paid vacation
  • Paid sick leave
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