Job Location : Gaithersburg,MD, USA
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MESO SCALE DIAGNOSTICS, LLC. provided pay rangeThis range is provided by MESO SCALE DIAGNOSTICS, LLC.. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.
Base pay range$116,600.00/yr - $177,800.00/yr
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Talent Acquisition Leader | Top Producer | People-Centric Innovator in Process ImprovementPOSITION SUMMARY:
The Engineering Manager I is responsible for managing and participating in product development activities through product release and managing feature additions to released products. This position is also responsible for managing design control activities including preparation of design and development plans, risk management, product requirements, specifications, formal verification, validation plans and reports.
DUTIES AND RESPONSIBILITIES:
Manage and participate in product development and product enhancement activities.
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.
Contribute to the development of hardware, software and assay requirements, and specifications for new 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.
Lead design control activities spanning feasibility, verification, design transfer, validation and launch.
Develop instrument training and troubleshooting procedures.
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
Train internal users and field service personnel.
Work 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 department requirements
EXPERIENCE AND QUALIFICATIONS:
Bachelor of Science degree in an engineering discipline required. Advanced degree in an engineering discipline preferred.
Ten years of relevant experience preferred
Two 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
Knowledge of integrating complex, automated life sciences or clinical systems preferred
Solid knowledge of product development processes, especially under Design Control
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
Demonstrated ability to meet deadlines, manage processes through to completion and coordinate a high level of activity under a variety of conditions and constraints
Excellent analytical and problem solving skills
o 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
o Effectively communicate issues/problems and results that impact timelines, accuracy and reliability of project data
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
Proficiency in MS Office suite
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.
Seniority levelReferrals increase your chances of interviewing at MESO SCALE DIAGNOSTICS, LLC. by 2x
Inferred from the description for this jobMedical insurance
Vision insurance
401(k)
Paid paternity leave
Paid maternity leave
Tuition assistance
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