Senior Mechanical Engineer Ii in Bedford

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.

Responsibilities:

• 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.

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.
• In vitro medical device experience highly desired.

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