Demo

Manager I, Engineering

Meso Scale Diagnostics, LLC.
Gaithersburg, MD Full Time
POSTED ON 2/2/2025
AVAILABLE BEFORE 3/1/2025

POSITION SUMMARY:

The Manager I, Engineering is responsible for planning and executing engineering of new Manufacturing Automation platforms and managing engineers and technicians performing mechanical, electrical participating in engineering work in the development of new automation platforms. In conducting this work, the Manager I, Engineering will work closely with other internal groups as well as external groups such as key vendors.



DUTIES AND RESPONSIBILITIES

  • Plan and execute engineering work to develop new Automation platforms and to support existing Automation platforms.
  • Assist with the development and management of project timelines and budgets and work to ensure project compliance with timelines and budgets and mitigation of timeline and budget risks.
  • Assist with the development and management of key documents such as requirements, specifications, verification and validation plans, FAT and SAT documents, among others.
  • Author project communications such as project status updates, key technical decisions, and test results.
  • Handle interactions and communications with other cross-functional teams including consumables manufacturing, process development, IT, and software teams.
  • Manage engineering work to ensure compliance with MSD’s quality systems including ISO9001 and ISO13485.
  • Manage the day-to-day work of engineers and technicians working on Automation platform development, Automation platform sustaining engineering projects, and Automation platform maintenance.
  • Handle interactions and communications with key vendors.
  • Effectively communicate issues/problems and results that impact timelines, accuracy and reliability of project status.
  • Work with consumables manufacturing and process development teams to gain information on Automation platform performance and reliability to ensure that continuous platform 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
  • A minimum of 7 years of industry relevant experience.
  • A minimum of 2 years of supervisory experience.
  • Experience in the Biotech or Pharmaceutical industries strongly preferred.
  • Experience with ISO, GMP, and/or Design Control strongly preferred.


KNOWLEDGE, SKILLS AND ABILITIES


  • Solid knowledge of product development processes, especially under Design Control.
  • Excellent analytical and problem solving skills. Demonstrated ability to organize and move project tasks forward in an orderly and structured fashion.
  • Solid 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
  • Demonstrated ability to meet deadlines, manage processes through to completion and coordinate a high level of activity under a variety of conditions and constraints.
  • Understanding of ISO and/or FDA cGMP standards and their documentation requirements.
  • Proficiency in MS Office suite and Automation software (e.g. PLC programming, C# programming, etc.)
  • Excellent oral, written and interpersonal skills.
  • Excellent documentation skills, technical writing and presentation skills.
  • A wide variety of creativity and latitude is expected including the ability to multi-task in an environment with changing priorities.


PHYSICAL DEMANDS

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 equipment building, light manufacturing, and engineering office environments.

COMPENSATION SUMMARY


The annual base salary for this position ranges from $113,600 to $173,300. 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.

Salary : $113,600 - $173,300

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