Summary
This position focuses on optimizing manufacturing processes to produce medical devices safely, efficiently, and to high quality standards. The role involves heavy day-to-day engagement with manufacturing operations to ensure equipment performs at optimal levels. A key focus will be using data-driven solutions for the continuous improvement of existing and new processes as well as supporting existing products through sustaining engineering activities. Success in this role requires a balance of analytical planning and direct, hands-on implementation and troubleshooting.
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
-
Project management experience preferred
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
If you're ready to make a difference and start a rewarding, growth-focused career, apply today! WillowWood is an Equal Opportunity Employer.
Applicants must be currently eligible to work in the United States without requiring employer sponsorship. Relocation not provided.
