Sr. Process Engineer

We are supporting a growing medical device manufacturer seeking a Senior Process Engineer to lead process development optimization validation and continuous improvement initiatives within a regulated manufacturing environment.

This individual will work across engineering quality and operations to develop robust manufacturing processes support new product introductions improve existing production and ensure processes meet quality regulatory and performance requirements.

The Senior Process Engineer will provide technical leadership for the development qualification and improvement of manufacturing processes involving injection molding extrusion assembly and related production technologies.

The ideal candidate brings strong hands-on process engineering experience a solid understanding of medical device manufacturing requirements and the ability to solve complex production and validation challenges.

• Design develop and optimize manufacturing processes for medical device components and assemblies
• Lead process validation activities including IQ OQ and PQ
• Support new product introduction process transfer scale-up and manufacturing readiness activities
• Troubleshoot manufacturing issues and lead root cause analysis for process deviations and nonconformances
• Develop and implement corrective and preventive actions
• Apply Lean Manufacturing Six Sigma DOE and statistical methods to improve yield cycle time quality and manufacturing efficiency
• Partner with Quality Engineering R&D Operations and other technical teams to ensure processes are robust compliant and production ready
• Author and maintain validation protocols reports work instructions process documentation and risk assessments
• Develop and maintain process FMEAs
• Evaluate and qualify equipment tooling fixtures and materials
• Provide technical guidance and mentorship to engineers and technicians
• Serve as a technical subject matter expert during audits and process reviews

• Bachelors degree in Mechanical Chemical Biomedical Materials Engineering or a related technical discipline
• 5 years of process manufacturing or related engineering experience within a regulated manufacturing environment
• Medical device experience strongly preferred
• Hands-on experience with injection molding and/or extrusion processes involving silicone thermoplastics or similar materials
• Experience with process validation including IQ OQ and PQ
• Working knowledge of ISO 13485 and applicable FDA medical device manufacturing requirements
• Experience with root cause analysis CAPA and FMEA methodologies
• Strong understanding of statistical process control and Design of Experiments
• Demonstrated ability to troubleshoot complex manufacturing and process issues
• Strong cross-functional communication and technical documentation skills

• Six Sigma Green Belt or Black Belt certification
• Experience within a high-mix or technically complex manufacturing environment
• Familiarity with cleanroom manufacturing
• Experience supporting equipment qualification and manufacturing scale-up
• Experience working directly with internal and external technical stakeholders