Associate Manufacturing Engineer

NACS, Inc.; Ham Lake (MN); In loco; USD 75.000 - 90.000; Tempo pieno

Descrizione del lavoro

Ascential Medical & Life Sciences in Ham Lake, MN is seeking a Manufacturing Engineer to design, implement, and optimize medical device manufacturing processes. You will develop SOPs/MBRs, validate equipment and systems, and drive continuous improvement using lean and Six Sigma methodologies.

Responsibilities include data analysis, risk assessment, change controls, CAPAs, and training production staff on new equipment and processes in a cGMP environment. Equal Opportunity Employer.

Competenze

• Bachelor's degree in Biomedical Engineering or Mechanical Engineering.
• Experience in cGMP manufacturing and validation activities.
• Familiarity with Lean/Six Sigma and change control processes.

Mansioni

• Participates in design, implementation, and optimization of manufacturing processing.
• Develops and maintains SOPs and Master Batch Records (MBRs).
• Monitors production data to identify trends and opportunities for improvement.
• Drives continuous improvement initiatives (lean manufacturing, Six Sigma).
• Validates manufacturing equipment and computer systems/software.
• Performs risk assessments on process steps and equipment.
• Supports qualification/validation activities and CAPAs.
• Provides technical training to production personnel on new equipment and processes.

Conoscenze

Lean manufacturing

Six Sigma

CAPA & change control

Formazione

Biomedical Engineering

Mechanical Engineering

Strumenti

Validation

GMP/computerized systems validation

FMEA

Descrizione del lavoro

Ascential Medical & Life Sciences
Ham Lake, MN 55304, USA

• Full-Time
• Requisition #: ASSOC001802

Description

• Participates in and supports the design, implementation, and optimization of manufacturing processing including but not limited to:
• Develop and maintain Standard Operating Procedures (SOPs), Master Batch Records (MBRs), and work instructions.
• Monitor and analyze production data to identify trends and opportunities for improvement.
• Improve efficiency, safety, and compliance, including existing and new processes.
• Participate in continuous improvement initiatives such as lean manufacturing and Six Sigma methodologies.
• Validation and implementation of manufacturing equipment and computer system/software validations.
• Conduct risk assessment on process steps and their ability to meet requirements.
• Improve manufacturing efficiency by analyzing and planning work flow, space requirements, and equipment layout.
• Identify and resolve technical issues impacting manufacturing performance.
• Provide technical support for troubleshooting equipment and process-related deviations.
• Assist in training production personnel on new equipment and processes.
• Ability to prepare/issue change controls, CAPAs, and investigations.
• Participates in and supports validation projects within the cGMP regulated manufacturing areas, including but not limited to:
  • Prepare, review, and execute commissioning, qualification and validation documents for equipment and computerized systems/software.
  • Supporting Project teams in: User Requirement Specifications, GMP Impact Assessments, Traceability Matrices, Design Qualifications, and Risk Assessments.
  • Ability to handle multiple commissioning, qualification, and validation priorities based on the needs of the manufacturing area and project team with guidance from management.
  • Assisting in troubleshooting of equipment/computer system issues, process characterization and root cause investigations.
  • Involved in resolving deviations/non-conformances observed during execution of qualification and validation activities.
  • Apply FMEA process to evaluate failure data, if necessary, from field data to find root cause and implement sound engineering solutions.

Salary range: $75,000 - $90,000 annually

Qualifications

Education

Preferred

Bachelors or better in Biomedical Engineering or related field.

Bachelors or better in Mechanical Engineering or related field.

Equal Opportunity Employer
This employer is required to notify all applicants of their rights pursuant to federal employment laws.For further information, please review the Know Your Rights notice from the Department of Labor.