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Lead Process Engineer

2 months ago

Columbia, Maryland, United States Aztec Full time
Transforming Lives and Careers


At Aztec, we believe in the power of innovation to change the landscape of healthcare. Joining our team means engaging in meaningful work that drives progress and enhances patient outcomes.

Role Overview

The Senior Process Engineer will play a pivotal role in collaborating with various departments including Production, Quality Assurance, Research & Development, and external partners. This position is crucial for managing capital projects, providing manufacturing support, and spearheading continuous improvement initiatives while adhering to both domestic and international Medical Device Regulations.

Key Responsibilities
  • Lead the investigation and resolution of manufacturing quality issues, implementing corrective and preventive measures.
  • Oversee the execution of capital projects, ensuring design, construction, commissioning, and qualification are completed on schedule and within budget.
  • Act as the technical lead for new product development, facilitating process validation and product launch planning.
  • Support the transition of small-scale processes into full-scale production, including necessary documentation and equipment development.
  • Drive continuous improvement initiatives aimed at enhancing production methods, equipment efficiency, and product quality.
  • Conduct process validations and author key documentation such as IQ, OQ, and PQ protocols.
  • Provide essential technical and project management support for capital projects.
  • Utilize Process Failure Mode and Effects Analysis (PFMEA) and Design of Experiments to optimize manufacturing processes.
  • Mentor junior engineers in good manufacturing practices and engineering principles.
Qualifications


To be successful in this role, candidates should possess:

  • A Bachelor's degree in Chemical Engineering, Mechanical Engineering, or a related field.
  • A minimum of 5 to 7 years of relevant industry experience, preferably in the medical device sector.
  • Strong leadership and mentoring capabilities.
  • Experience in managing and executing cross-functional projects.
  • Familiarity with Lean Six Sigma methodologies is advantageous.
  • Proficiency in statistical analysis and project management.
Work Environment

This position requires the ability to work in both office and manufacturing settings, with occasional travel. Candidates should be comfortable in a cleanroom environment and able to adapt to varying noise levels.

Commitment to Diversity

Aztec is an equal opportunity employer, dedicated to fostering an inclusive workplace for all qualified applicants and employees.