Associate Manufacturing Engineer: Lean & Validation Focus

NACS, Inc.; Ham Lake (MN); On-site; USD 75,000 - 90,000; Full time

Job summary

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.

Qualifications

• 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.

Responsibilities

• 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.

Skills

Lean manufacturing

Six Sigma

CAPA & change control

Education

Biomedical Engineering

Mechanical Engineering

Tools

Validation

GMP/computerized systems validation

FMEA

Job description

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.