Manufacturing Engineer M&A Operations Integration

About the position

The position involves supporting medical device manufacturing with a focus on cleaning and upgrade validations. The candidate will be responsible for process characterization, equipment IQ/OQ, process OQ, and PQ, as well as test method validation and Gage R&R. The role requires experience in root cause analysis and problem-solving for both technical and process issues, along with a working knowledge of design control and cGMP requirements for medical device manufacturing as per FDA QSR and ISO13485-2003. The candidate must be able to lead and prioritize multiple medium-complexity project assignments and complete work in a timely manner. Good problem-solving skills using quality and statistical tools are essential, as well as the ability to read and understand engineering drawings. The role also involves creating and updating BOMs and routers, and working effectively within a cross-functional team to complete critical project tasks.

Responsibilities

• Supporting medical device manufacturing
• Process characterization, equipment IQ/OQ, process OQ, and PQ
• Test method Validation, Gage R&R
• Creating, maintaining, and improving controlled technical documents such as prints, procedures, bills of materials, and routers
• Supporting a wide variety of processing applications such as machining, finishing, forging, casting, cleaning, heat treating, bonding, molding, etc.
• Conducting feasibility study to estimate a product cost and analyze capital equipment, capacity, and capability requirements
• Establishing and improving process methods that meet performance and quality requirements
• Developing and executing project plans and schedules for work activities
• Communicate (written and verbal) direction and project plans with appropriate personnel from other departments
• Evaluating multiple options to select the most appropriate processes and machining methods
• Execute equipment qualification or process validation

Requirements

• Experience supporting medical device manufacturing
• Cleaning & Upgrade Validations
• Specific experience with process characterization, equipment IQ/OQ, process OQ, and PQ
• Specific experience with Test method Validation and Gage R&R
• Experience with root cause analysis and problem-solving for both technical and process issues
• Working knowledge of design control and cGMP requirements for medical device manufacturing per FDA QSR and ISO13485-2003
• Ability to lead and prioritize multiple medium-complexity project assignments and complete work in a timely manner
• Good problem-solving skills using quality and statistical tools
• BOM & Router creation and update
• Ability to read and understand engineering drawings
• Knowledge of basic quality tools, risk analysis (PFMEA), statistics (SPC), Critical-to Quality (CTQ) Analysis
• Knowledge of Quality System requirements, ISO and FDA requirements
• Ability to effectively work within a cross-functional team to complete critical project tasks
• Demonstrates good written and verbal communication skills
• Experienced with control procedures, such as the Change Management System, Nonconformance Reports, Engineering Specifications, Corrective and Preventive Action (CAPA), and Work Instructions
• Proficient with Statistical Process Control concepts, process development, CNC programming terminology, and tooling design concepts
• Microsoft Office Suite and Project

Benefits

• Discretionary Annual Incentive
• Comprehensive Medical Coverage: Medical & Health, Dental & Vision, Disability Planning & Insurance, Pet Insurance Plans
• Family Support: Maternal & Parental Leaves
• Insurance Options: Auto & Home Insurance, Identity Theft Protection
• Convenience & Professional Growth: Commuter Benefits & Certification & Training Reimbursement
• Time Off: Vacation, Time Off, Sick Leave & Holidays
• Legal & Financial Assistance: Legal Assistance, 401K Plan, Performance Bonus, College Fund, Student Loan Refinancing