Engineer IV, Mechanical

MESO SCALE DIAGNOSTICS, LLC. • Gaithersburg, MD

1d • $116,600 - $177,800

About The Position

The
Mechanical Engineer IV is responsible for setting goals and objectives for
the development of new instrumentation and support of existing instrumentation
for the biodefense, clinical and life-science markets. Design work will include
the design of precision mechanisms and complex assemblies that include machined,
molded and sheet-metal components. The incumbent is responsible for providing
general oversight to teams performing of the planning, documentation,
prototyping and testing of designs.

Requirements

• Bachelor’s degree in Mechanical Engineering, Master’s or Ph.D. degree in Mechanical or Industrial Engineering 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
• Proficiency and knowledge of GD&T tolerancing practices required
• Advanced understanding of manufacturing technologies including machining, molding and sheet metal processes
• Strong engineering fundamentals and analytical background
• Logical problem solving and demonstrated ability to organize and move project tasks forward in an orderly and structured fashion
• Excellent oral, written, and interpersonal communication skills
• Effectively communicate issues/problems and results that impact timelines, accuracy and reliability of project data
• Demonstrated propensity to be creative, collaborative, proactive, and self-motivated in the execution and completion of assigned accountabilities.
• Proficiency with Solidworks, I-DEAS, Pro/Engineer, or other comparable advanced CAD software.
• Proficiency in MS Office suite
• A wide degree of creativity and latitude is expected including the ability to multi-task in an environment with changing priorities
• Demonstrated ability to develop, integrate and validate systems, in a GMP, ISO or other regulated production environment

Nice To Haves

• Experience with integrating complex electromechanical systems, precision fluidics and thermall 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
• Working knowledge of the manufacture of FDA regulated devices is a plus

Responsibilities

• Contributes to the overall strategies/goals and objectives of the department.
• 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 as required. Lead the development and implementation of test protocols for both informal and formal design testing
• Provide oversight to the planning, design, build and testing of manufacturing test fixtures to support production of new instrumentation
• 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 relevant design control documentation
• Participate in and lead electromechanical and systems integration activities as required.
• Specific duties may vary depending upon department requirements

Benefits

• At MSD, we offer a comprehensive benefits package to support our employees' well-being and financial security.
• In addition to competitive salaries, our benefits include medical, dental, and vision coverage, along with prescription benefits.
• We provide a 401(k) plan with company matching, flexible spending accounts, and company-paid short- and long-term disability insurance as well as group life and accidental death and dismemberment insurance.
• Our offerings also encompass paid vacation, paid sick leave, paid holidays, and paid parental leave, along with an employee assistance program.
• Additional voluntary perks include a fitness club membership contribution, pet insurance, identity theft protection, home and auto insurance discounts, and optional supplemental life insurance.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 251-500 employees