Manufacturing Engineer

Primary Responsibilities

• Work independently and within project teams to establish and achieve manufacturing improvement goals.
• Drive sustaining engineering activities to ensure performance and adherence to industry standards while maintaining product continuity for customers.
• Collaborate and coordinate with new vendors for materials, material replacements, supply chain, and equipment needs.
• Identify and address efficiency bottlenecks and process shortcomings.
• Lead root cause analysis (RCA) to drive process efficiency and reduce quality defects.
• Perform data analysis to support and drive decisions for current and future process improvements.
• Define specifications for new and existing equipment
• Assess and qualify new suppliers, conduct technical reviews of materials or machine information
• Assess existing equipment to identify safety concerns and recommend necessary upgrades
• Identify, secure, and implement updates to equipment to support manufacturing demand.
• Lead efforts to meet ISO 13485 requirements for process implementation and validation (IQ/OQ/PQ).
• Ensure manufacturing equipment runs at optimal performance to meet safety, quality, and customer demand requirements.
• Ensure change management procedures are followed and changes (ECOs) are properly validated and documented per the Quality Management System (QMS).
• Maintain manufacturing documentation, including component drawings and specifications, inspection plans, bills of materials (BOM), assembly/packaging drawings, SOPs, work instructions, quality plans, and other required documents.
• Ensure all documentation complies with company quality system and customer requirements.
• Participation in internal and external quality audits, CAPA investigations, etc., as needed

Education and Experience

• Bachelor's degree in mechanical engineering (or related field) (ABET-accredited)
• 3+ years of applied professional experience in sustaining engineering or process engineering
• PREFERRED: Medical device manufacturing experience, with understanding of ISO 13485 and ISO 14971
• PREFERRED: Project management experience

Essential Knowledge, Skills and Abilities

• Strong mechanical aptitude and high attention to detail
• Exceptional indirect leadership and cross-functional influence capabilities
• Strong written and verbal communication skills; comfortable presenting data and proposals in meeting settings.
• Ability to communicate and coordinate with contractors to consult on requirements for process equipment.
• Remains composed and level-headed in time-sensitive situations and when working with multiple stakeholders, navigating differing perspectives to find collaborative solutions
• Ability to prioritize tasks and manage a diverse workload of various project timelines and complexities
• Excellent organizational and project management skills
• Detailed record-keeping and documentation practices that adhere to the QMS.
• Working knowledge of GMP, ISO 13485, MDD/MDR compliance, and safety.
• Awareness or demonstrated use of Lean/Six Sigma tools (FMEA, DOE, Gauge R&R...)
• Proficiency with SolidWorks (or comparable), including modeling, drawings, and assemblies
• Proficiency with MS Office applications
• Proficiency in technical writing
• PREFERRED: Experience in a manufacturing environment, including working around a wide variety of processes and equipment