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MESO SCALE DIAGNOSTICS, LLC.

Manager I, Engineering

MESO SCALE DIAGNOSTICS, LLC., Gaithersburg, Maryland, us, 20883

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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. 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. 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. 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 $116,600 to $177,800. Benefits Summary At MSD, we offer a comprehensive benefits package to support our employees' well-being and financial security. EEO/AA STATEMENT MSD is an Equal Opportunity/Affirmative Action Employer.

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