Manufacturing Engineer

Job Description

- Protocol Review & Compliance: Study and assess Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols and reports for regulatory and procedural compliance.

- Process Audits & Documentation: Conduct thorough audits of manufacturing processes to identify documentation gaps. Update Quality Management System (QMS) documents to reflect findings and ensure alignment with current standards.

- Process Optimization: Design and execute Design of Experiments (DoE) to optimize process parameters for CNC Machining and Comestibles and document robust process parameters and operating windows.

- Validation Execution: Execute or re-execute validation protocols including sample measurements and data collection. Generate comprehensive IQ, OQ, PQ reports based on validation activities.

- Statistical Analysis: Run statistical reports to analyze process capability, variability, and performance trends.

- Change Management: Lead and document change management activities related to process improvements and equipment modifications.

- Continuous Monitoring: Monitor validated process parameters to ensure equipment and processes remain in a validated state. Implement controls and corrective actions as needed to maintain compliance.

- Collaborate with Quality Engineering to provide manufacturing support.

- Responsible for providing manufacturing engineering support to specific projects including change analysis, risk analysis, and manufacturing readiness.

- Should be experienced in medical device manufacturing assembly lines

- Troubleshoot and resolve issues relating to safety, efficacy, quality, cost, or delivery of components and finished devices.

- Need to conduct qualification, verification, and validation activities to produce medical devices.

- Need to be responsible for completing engineering work and contribute to new product development teams and product support, typically including the following activities: technology development, test of materials or products, preparation of specifications, six sigma, process studies, process improvements, and report preparation.

- Participate in cross-functional project teams. Coordinate, manage, and document project work and progress, and recommend appropriate revisions.

- Work with CFT teams in troubleshooting problems on the production floor.

Skills Required

- Experience working in QMS and ERP systems

- Experience with IQ/OQ/PQ/TMV preferred

- Worked with cross functional teams

- 5+ years of experience in medical device manufacturing, with hands-on experience in CNC Machining and DCM.

- Strong understanding of FDA, ISO 13485, and GMP requirements.

- Proficiency in statistical analysis tools (e.g., Minitab, JMP).

- Experience with QMS systems and documentation practices.

- Excellent analytical, problem-solving, and communication skills.

Education/Training/Certifications

- Bachelor's or Master's degree in Mechanical Engineering, Biomedical Engineering, or related field.

We are an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, sex, sexual orientation, age, national origin, disability, protected veteran status, gender identity or any other factor protected by applicable federal, state, or local laws.

JOB-10044779