Manufacturing Engineer II

Key Responsibilities

• Lead and execute validation activities, including:
  • Process Validation (PV)
  • Software Validation
  • IQ (Installation Qualification)
  • OQ (Operational Qualification)
  • PPQ (Performance Qualification)
• Develop, author, and maintain quality system documentation, including:
  • Validation protocols and reports
  • Manufacturing instructions
  • Test methods and technical documentation
• Support engineering change activities, including:
  • Print updates using SolidWorks
  • Process and inspection updates
• Document control within systems such as Windchill
• Partner with cross-functional teams (Manufacturing, Quality, Regulatory, R&D) to:
• Execute validation and process improvement initiatives
• Support ongoing production and issue resolution
• Ensure compliance with applicable regulatory and quality standards
• Work directly with production personnel in a cleanroom environment to:
• Support implementation of validated processes
• Troubleshoot manufacturing challenges
• Contribute to process development activities, including:
• Supporting or leading development efforts in lab environments
• Evaluating and implementing process improvements
• Identify and anticipate technical challenges; develop and recommend solutions where standard practices may not exist
• Apply structured problem-solving and sound engineering judgment, considering broader system impacts
• Participate in peer reviews of engineering work, validation strategies, and documentation
• Support broader team and organizational initiatives as needed

Requirements

Commensurate with experience

Qualifications

• Bachelor's degree in Engineering or related field
• Minimum of 5 years of relevant experience in contract manufacturing or related field
• Experience with validation methodologies and quality system documentation
• Strong understanding of regulatory requirements and industry best practices
• Proficiency in SolidWorks and Windchill
• Excellent communication and collaboration skills

Skills

• Technical expertise in manufacturing systems
• Proven ability to lead validation activities
• Strong problem-solving and analytical skills
• Ability to work effectively in a cross-functional team environment
• Knowledge of regulatory and quality standards
• Experience in a regulated medical device environment

Benefits

• Medical and Prescription Drug Plans
• Dental Plan
• Vision Plan
• Health Savings Account (for High-Deductible Health Plans)
• Flexible Spending Accounts (Health, Limited Purpose, Dependent Care, Commuter Parking and Commuter Transit)
• Supplemental Life Insurance
• Short Term Disability (coverage varies by state)
• Long Term Disability
• Critical Illness, Hospital coverage, Accident Insurance
• MetLife Legal, MetLife ID Fraud, and MetLife Pet Insurance
• 401(k)