Manager I, Engineering

$113,600 - $173,300/Yr

Meso Scale Diagnostics, Llc. - Gaithersburg, MD

Full-time - Manager

Gaithersburg, MD

Computer and Electronic Product Manufacturing

About the position

The Manager I, Engineering is responsible for overseeing the planning and execution of engineering projects related to new Manufacturing Automation platforms. This role involves managing a team of engineers and technicians, ensuring compliance with quality systems, and collaborating with various internal and external stakeholders to achieve project goals.

Responsibilities

• Plan and execute engineering work to develop new Automation platforms and support existing ones.
• Assist with the development and management of project timelines and budgets, ensuring compliance and mitigating risks.
• Develop and manage key documents such as requirements, specifications, and validation plans.
• Author project communications including status updates and key technical decisions.
• Handle interactions and communications with cross-functional teams and key vendors.
• Manage engineering work to ensure compliance with quality systems including ISO9001 and ISO13485.
• Oversee the day-to-day work of engineers and technicians on Automation platform projects.
• Communicate issues and results impacting project timelines and reliability.
• Work with manufacturing and process development teams to improve Automation platform performance.

Requirements

• 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.
• Solid knowledge of product development processes, especially under Design Control.
• Excellent analytical and problem-solving skills.
• Solid leadership skills and understanding of staff management practices.
• Demonstrated ability to meet deadlines and manage processes effectively.
• Understanding of ISO and/or FDA cGMP standards and documentation requirements.
• Proficiency in MS Office suite and Automation software (e.g. PLC programming, C# programming).
• Excellent oral, written, and interpersonal skills.

Nice-to-haves

• Experience with project management tools and methodologies.
• Familiarity with automation technologies and systems.

Benefits

• Medical, dental, and vision coverage
• Prescription benefits
• 401(k) plan with company matching
• Flexible spending accounts
• Company-paid short- and long-term disability insurance
• Group life and accidental death and dismemberment insurance
• Paid vacation
• Paid sick leave
• Paid holidays
• Paid parental leave
• Employee assistance program
• Fitness club membership contribution
• Pet insurance
• Identity theft protection
• Home and auto insurance discounts
• Optional supplemental life insurance