Senior Mechanical Design Engineer, Instrumentation

Meso Scale Diagnostics LLC; Gaithersburg (MD); On-site; USD 116,600 - 177,800; Full time

Benefits offered by this job

Medical benefits

Dental coverage

Vision coverage

401(k) plan with company matching

Job summary

Meso Scale Diagnostics LLC is seeking a senior Mechanical Engineer IV to set goals for new instrumentation development and support existing devices for biodefense, clinical and life-science markets. You will design precision mechanisms and complex assemblies, while guiding planning, prototyping and testing activities.

You will lead cross-functional teams, develop requirements, and present designs to management.

Qualifications

• Bachelor's degree in Mechanical Engineering; Master's or Ph.D. preferred.
• Minimum 15 years of relevant experience preferred.
• Medical or scientific instrument and/or consumables design experience required.
• Experience in an ISO cGMP environment required.
• Demonstrated CAD experience is required.
• Experience with integrating complex electromechanical systems, precision fluidics and thermal management systems strongly desired.
• Experience in the design of injection molded components strongly preferred.
• Experience in the design of electromechanical systems strongly preferred.
• Experience with heat management and temperature controls strongly preferred.

Responsibilities

• Leads cross-functional teams to support the design and development of MSD instrumentation.
• Lead the mechanical design, prototyping, testing, and troubleshooting of new instrumentation designs.
• Contribute to the development of requirements and specifications for new instrumentation.
• Present designs, engineering issues, and solutions to senior engineering and company management.
• Lead the development and implementation of test protocols for design testing.
• Provide oversight to planning, design, build and testing of manufacturing test fixtures.
• Oversee the development of written assembly and test procedures for new instrumentation designs.
• Interact with outside vendors and MSD's supplier quality department to source and qualify parts.
• Perform design and development work in conformance with ISO and FDA cGMP processes.
• Lead the development of design control documentation.
• Participate in and lead electromechanical and systems integration activities.

Skills

GD&T tolerancing

CAD software

Manufacturing processes

Problem solving

Communication skills

ISO cGMP knowledge

Education

Bachelors in Mechanical Engineering

Advanced degree preferred (MS/PhD)

Tools

SolidWorks

I-DEAS

Pro/Engineer

Job description

Meso Scale Diagnostics LLC is seeking a senior Mechanical Engineer IV to set goals for new instrumentation development and support existing devices for biodefense, clinical and life-science markets. You will design precision mechanisms and complex assemblies, while guiding planning, prototyping and testing activities.

You will lead cross-functional teams, develop requirements, and present designs to management.