Director I, Engineering

Reposted 9 Days Ago
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Gaithersburg, MD, USA
In-Office
151K-237K Annually
Expert/Leader
Biotech
The Role
Lead cross-functional teams to design, develop, verify, validate, launch, and sustain MSD instrumentation products. Manage schedules, budgets, documentation, system integration, testing, and regulatory compliance (ISO9001/ISO13485, cGMP). Coach and develop engineering staff, coordinate with vendors and service teams, and drive continuous product improvement.
Summary Generated by Built In

POSITION SUMMARY:
The Director I, Engineering is responsible for leading major engineering projects under the supervision of the VP of Engineering. The Director I, Engineering will lead and manage engineers and technicians participating in product development and product enhancement activities. In conducting this work, the Director I, Engineering will work closely with other 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

  • 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 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

  • Author 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

  • 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
    • Ten years of relevant experience  or a combined ten years of relevant experience and postgraduate education leading to a degree required  
    • Four years of direct or matrixed supervisory experience required


    KNOWLEDGE, SKILLS AND ABILITIES:

    • Strong knowledge of medical or scientific instrument and/or consumables design required
    • Strong knowledge of compliance requirements of an ISO cGMP environment required
    • Solid 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
    • 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.
    • Demonstrated ability to meet deadlines, manage processes through to completion and coordinate a high level of activity under a variety of conditions and constraints
    • 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

COMPENSATION SUMMARY

The annual base salary for this position ranges from $151,400 to $236,600. 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
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.

Top Skills

Cgmp
Design Control
Iso13485
Iso9001
MS Office
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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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