Engineer II, Mechanical

Posted 2 Days Ago
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Gaithersburg, MD, USA
In-Office
88K-134K Annually
Senior level
Biotech
The Role
Designs, prototypes, tests, troubleshoots, and documents precision mechanical components, assemblies, and instrumentation for biodefense, clinical, and life-science applications. Develops specifications, test protocols, manufacturing fixtures, assembly procedures, and supports production. Collaborates cross-functionally and with vendors while ensuring compliance with ISO and FDA cGMP requirements. The role involves CAD design, electromechanical systems, injection molding, machining, sheet metal manufacturing, and regulated product development.
Summary Generated by Built In

POSITION SUMMARY:

The Mechanical Engineer is responsible for mechanical design, testing, and documentation responsibilities in 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.

DUTIES AND RESPONSIBILITIES

  • Work within cross-functional teams to support the design and development of MSD instrumentation.
  • Design, prototype, test, and troubleshoot new and existing instrumentation designs.
  • Contribute to the development of specifications for new instrumentation.
  • Develop and execute test protocols for both informal and formal design testing.
  • Design, build, and test manufacturing test fixtures to support production of new instrumentation.
  • Prepare assembly and test procedures for new instrumentation designs.
  • Interact with outside vendors to source parts.
  • Perform design and development work in conformance with ISO and FDA cGMP processes.
  • Specific duties may vary depending upon department requirements.

EXPERIENCE AND QUALIFICATIONS

  • Bachelor’s degree in Mechanical Engineering, Master’s degree in Mechanical or Industrial Engineering, preferred
  • Minimum 5 years of relevant experience preferred
  • Medical or scientific instrument design experience preferred
  • Experience in an ISO cGMP environment preferred
  • Demonstrated CAD experience is required 

KNOWLEDGE, SKILLS AND ABILITIES

  • Knowledge of the design of injection molded components desired.
  • Knowledge of the design of electromechanical systems desired.
  • Demonstrated understanding of GD&T tolerancing practices preferred.
  • Solid 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
  • Solid knowledge of SolidWorks, I-DEAS, Pro/Engineer, or AutoCAD is preferred 
  • 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 is preferred
  • Working knowledge of the manufacture of FDA regulated devises 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 office.

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 $88,100 to $134,400. 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
  • Master's degree in Mechanical or Industrial Engineering
  • Minimum 5 years of relevant experience
  • Demonstrated CAD experience
  • Medical or scientific instrument design experience
  • Experience in an ISO cGMP environment
  • Knowledge of injection-molded component design
  • Knowledge of electromechanical systems design
  • Understanding of GD&T tolerancing practices
  • Knowledge of machining, molding, and sheet metal manufacturing technologies
  • Strong engineering fundamentals and analytical background
  • Excellent oral, written, and interpersonal communication skills
  • Knowledge of SolidWorks, I-DEAS, Pro/Engineer, or AutoCAD
  • Proficiency in Microsoft Office
  • 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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