Senior Manufacturing Engineer-Medical Device

Job Summary:

The Senior Manufacturing Engineer will support manufacturing operations with a strong focus on process validation, quality, output and yield improvement. This role collaborates closely with operations, quality and supervisory teams to resolve line issues, enhance processes and maintain compliance. The engineer will act as a subject matter expert for products and processes, lead improvement initiatives and support sustaining engineering activities within the department.

Key Responsibilities:

• Own process validation activities including protocols and technical reports for POQ and PPQ

• Author, execute and report Inspection Method Validations and Test Method Validations

• Oversee assigned manufacturing line output, safety, yield and quality; identify defects and implement corrective actions

• Partner with line support teams to triage issues, assess non-conformances and drive containment and corrective actions

• Maintain strong product and process knowledge and provide expertise in statistics and engineering processes

• Model and draft assemblies, fixtures and tools using intermediate to advanced SolidWorks

• Provide engineering solutions such as tooling and manufacturing aids from concept to implementation

• Support equipment availability through troubleshooting and coordination with technicians and supervisors

• Contribute to training and certification programs with recommendations for improvement

• Determine quality impact of out-of-tolerance documents

• Execute change management activities for material, equipment and process changes including CO and CR generation

• Lead and support continuous improvement projects and CAPA implementations

• Conduct root cause analysis using DMAIC and A3 methodologies for complex manufacturing issues

• Perform line studies and validations as required

• Serve as the manufacturing engineering representative for yield, productivity, safety and other operational projects

• Coordinate product builds through the NPI process

• Generate changes within the eLHR system

• Lead manufacturing engineering support during external and internal audits

• Mentor junior engineers and technical staff

• Perform and lead statistical analysis for complex events

• Generate qualification and validation protocols and reports with minimal oversight

• Evaluate regulatory implications of proposed changes and support documentation for regulatory filings

• Make informed, timely decisions while considering risk mitigation and lessons learned

• Communicate effectively across functions and participate in cross-functional reviews

• Lead high-complexity manufacturing engineering projects including CIPs, CAPAs and validations

• May act as delegate for area management when needed

Required Qualifications:

• Bachelor's degree in Engineering or related discipline

• Minimum of five years of experience in manufacturing or process engineering

• Experience with process validations

• Catheter assembly experience

• Knowledge of applicable U.S. and international regulations

• Proficiency in Word, Excel and PowerPoint

• Strong statistical analysis skills

• SolidWorks proficiency with 3-D modeling

• Excellent communication and interpersonal skills with the ability to work across all levels

Preferred Qualifications:

• Experience leading high-complexity validations or CAPA activities

• Experience supporting audits and change management activities

Benefits:

The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan, life insurance, long-term disability insurance, short-term disability insurance, paid parking/public transportation, paid time off, paid sick and safe time, hours of paid vacation time, weeks of paid parental leave, and paid holidays annually – as applicable.

Pay Range: $50/hr to $52/hr