MESO SCALE DIAGNOSTICS, LLC.

Director III, Engineering

Position Summary

The Director III, Engineering is responsible for working with the Vice President of Engineering to develop the department’s strategy and directing vital engineering projects. The Director III, Engineering will oversee managers and engineers in multiple business units that participate in product development and product enhancement activities. In conducting this work, the Director III, Engineering will work closely with multiple internal groups as well as external groups such as key vendors.

Duties And Responsibilities

  • Lead cross-functional teams in the design and development of MSD instrumentation products, including:
    • Develop project proposal documents including project schedules and budgets
    • Develop product documentation such as product requirements and specification documents
    • Manage the design and development of MSD instrumentation products against product requirements, specifications, schedule, and budget
    • Manage the system integration and engineering testing of MSD instrumentation products
    • Manage the formal verification and validation of MSD instrumentation products
    • Manage the launch and post-launch sustaining engineering of MSD instrumentation products
  • Establishes, communicates, and implements engineering and development policies, practices, standards, and security measures to ensure effective and consistent operations.
  • Contributes to developing and managing the budget of multiple business units.
  • Work with cross-departmental teams to support the design, development integration, production and after sales support of MSD instrumentation, associated test kits, consumables and reagents.
  • Manage, coach and develop managers and other team members while motivating them to meet and exceed goals. Promote a culture of high performance and continuous improvement that values learning and a commitment to quality.
  • Oversee and review/approve project communications such as project status updates, key technical decisions, and test results.
  • Manage engineering work to ensure compliance with MSD’s quality systems including ISO9001 and ISO13485.
  • Lead collaboration efforts with service team to gain information on instrument field performance and reliability to ensure that continuous product improvement is in place.
  • Develop strategic plans for instrumentation product lines that consider advances in applicable engineering and scientific technologies, MSD’s product portfolio and business objectives, and competitor positions and tactics.
  • Anticipate possible business challenges, internally and externally, and develops and recommends improvements to achieve desired results. Specific duties may vary depending upon departmental requirements.

Experience And Qualifications

  • Bachelor’s degree in Systems, Mechanical, or Electrical Engineering or a closely related field required.
    • Post graduate degree preferred
  • Fifteen (15) years of relevant experience or a combined ten years of relevant experience and postgraduate education leading to a degree required.
  • Seven years of direct or matrixed supervisory experience required.

Knowledge, Skills And Abilities

  • Expert-level knowledge of medical or scientific instrument and/or consumables design required.
  • Expert-level knowledge of compliance requirements of an ISO cGMP environment required.
  • Strong knowledge of analytical techniques, experimental design, and statistical analysis preferred.
  • Strong leadership skills with demonstrated knowledge and understanding of staff management practices and processes and the ability to establish accountabilities and expectations and manage performance to achieve results.
  • Knowledge of business operations, including effective budget development and management processes, as well as the ability to translate strategic thinking into action plans and related outcomes.
  • Strong business acumen, negotiation and mediation skills, as well as a demonstrated attention to detail and a focus on achieving quality outcomes. Ability to build/foster relationships.
  • A professional presence and strong interpersonal skills for interacting in a courteous, timely, and diplomatic manner with all levels of employees as well as other parties/stakeholders involved in the company.
  • Demonstrated ability to meet deadlines, manage processes through to completion and coordinate a high level of activity under a variety of conditions and constraints.
  • Expert knowledge of integrating complex, automated life sciences or clinical systems required.
  • Solid knowledge of product development processes, especially under Design Control.
  • Excellent analytical and problem-solving skills
    • Logical problem solving and demonstrated ability to organize and move project tasks forward in an orderly and structured fashion
  • Excellent oral, written and interpersonal skills
    • Effectively communicate issues/problems and results that impact timelines, accuracy and reliability of project status
  • A wide variety 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.
  • Proficiency in MS Office suite.

PHYSICAL DEMANDS

While performing the duties of this job, the individual is frequently required to sit or 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
  • Seniority level

    Director
  • Employment type

    Full-time
  • Job function

    Engineering and Information Technology
  • Industries

    Biotechnology Research

Referrals increase your chances of interviewing at MESO SCALE DIAGNOSTICS, LLC. by 2x

See who you know

Get notified about new Director of Engineering jobs in Gaithersburg, MD.

Sign in to create job alert

Similar jobs

People also viewed

Similar Searches

Explore collaborative articles

We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.

Explore More