Engineer IV, Mechanical

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

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 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.

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.