Engineer IV, Mechanical

Posted 12 Days Ago
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Gaithersburg, MD, USA
Hybrid
117K-178K Annually
Expert/Leader
Biotech
The Role
Leads mechanical design and development of precision instrumentation for biodefense, clinical, and life-science applications. Oversees cross-functional teams, prototyping, testing, troubleshooting, systems integration, manufacturing fixtures, design documentation, and assembly procedures. Develops requirements, test protocols, and design controls while working with vendors and quality teams. Ensures compliance with ISO and FDA cGMP processes and supports electromechanical, fluidics, thermal management, molded, machined, and sheet-metal component design.
Summary Generated by Built In

POSITION SUMMARY

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.

DUTIES AND 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

EXPERIENCE AND QUALIFICATIONS

  • 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
  • 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

KNOWLEDGE, SKILLS AND ABILITIES

  •  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
  • Working knowledge of the manufacture of FDA regulated devices is a plus

PHYSICAL DEMANDS

While performing the duties of this job, the individual is frequently required to sit and stand for long periods. The individual is occasionally required to walk; use hands and fingers to operate, handle, or feel objects, tools, or controls; reach with hands and arms.

This position requires the ability to communicate and exchange information, utilize equipment necessary to perform the job, and move about the workplace.

WORK ENVIRONMENT

This position is performed in R&D, light-manufacturing, and engineering office environments.

COMPENSATION SUMMARY

The annual base salary for this position ranges from $116,600 to $177,800. This salary range represents a general guideline as MSD considers other factors when presenting an offer of employment, such as scope and responsibilities of the position, external market factors, and the candidate’s knowledge, skills, abilities, education and experience. Employees may qualify for a discretionary or non-discretionary bonus in addition to their base salary. These annual bonuses are intended to recognize individual performance and enable employees to benefit from the Company's overall success.

BENEFITS SUMMARY

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.

EEO/AA STATEMENT

MSD is an Equal Opportunity/Affirmative Action Employer. We are committed to fostering a diverse and inclusive workplace where all individuals are treated with respect and dignity. We welcome applications from all qualified candidates, making employment decisions without regard to race, color, religion, creed, sex, sexual orientation, gender identity, genetic information, marital status, national origin, age, protected veteran status, pregnancy, disability status, or any other protected characteristic. For our full EEO/AA and Pay Transparency statement, please visit here. Meso Scale Diagnostics uses E-Verify to validate the work eligibility of candidates.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.

Skills Required

  • Bachelor's degree in Mechanical Engineering
  • Minimum 15 years of relevant experience
  • Medical or scientific instrument and/or consumables design experience
  • Experience in an ISO cGMP environment
  • Demonstrated CAD experience
  • Master's or Ph.D. degree in Mechanical or Industrial Engineering
  • Experience integrating complex electromechanical systems, precision fluidics, and thermal management systems
  • Experience designing injection-molded components
  • Experience designing electromechanical systems
  • Experience with heat management and temperature controls
  • Proficiency with GD&T tolerancing practices
  • Understanding of machining, molding, and sheet-metal manufacturing technologies
  • Proficiency with SolidWorks, I-DEAS, Pro/Engineer, or comparable advanced CAD software
  • Proficiency with Microsoft Office Suite
  • Ability to develop, integrate, and validate systems in a GMP, ISO, or regulated production environment
  • Working knowledge of manufacturing FDA-regulated devices
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The Company
HQ: Rockville, MD
707 Employees
Year Founded: 1995

What We Do

Founded in 1995, Meso Scale Discovery (MSD) is a global leader in the development, manufacture, and commercialization of innovative assays and instruments for the measurement of molecules in biological samples. MSD’s proprietary MULTI ARRAY technology enhances medical research and drug development by enabling researchers to profile many biomarkers simultaneously in a single sample without compromising assay performance. MSD’s technology has been widely adopted by researchers in pharmaceutical companies, government institutions, universities, and clinical laboratories worldwide for its high sensitivity, excellent reproducibility, and wide dynamic range. Throughout its history, MSD has continued to evolve its technology platform to enable researchers to solve complex biological questions and, as the Company looks toward the future, it is expanding into clinical applications and the emerging fields of personalized medicine and companion diagnostics.

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