Manufacturing Engineer II
Abbott
Title: Manufacturing Engineer II Location: St. Paul, MN Duration: 7 Months
Shifts: 8AM TO 4:30PM 100% Onsite Summary The Contract Manufacturing Engineer II applies technical expertise and knowledge of manufacturing systems to support Abbott's business objectives. This role plays a proactive part in contract manufacturing operations, focusing on validation, process improvement, and quality system execution within a regulated medical device environment. The engineer collaborates cross-functionally to ensure robust manufacturing processes, compliant documentation, and successful validation activities supporting tissue heart valve and delivery system products. Key Responsibilities
Shifts: 8AM TO 4:30PM 100% Onsite Summary The Contract Manufacturing Engineer II applies technical expertise and knowledge of manufacturing systems to support Abbott's business objectives. This role plays a proactive part in contract manufacturing operations, focusing on validation, process improvement, and quality system execution within a regulated medical device environment. The engineer collaborates cross-functionally to ensure robust manufacturing processes, compliant documentation, and successful validation activities supporting tissue heart valve and delivery system products. 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
- 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)
- Published on 29 Jun 2026, 7:24 PM
Vacancy posted 4 days ago
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