PRIMARY PURPOSEThe Manufacturing Engineer II supports the development, improvement, and production readiness of medical diagnostic instruments by enhancing product reliability, manufacturability, and manufacturing processes. This position collaborates with Engineering, Manufacturing, Quality, Supply Chain, and external suppliers to resolve complex issues involving sensors, electronics, production processes, and manufacturing test systems.
KEY RESPONSIBILITIES AND ESSENTIAL FUNCTIONS- New Product Introduction
- Transition medical diagnostic products from design to production by developing manufacturing processes, risk-based controls, and production work instructions.
- Plan and execute pre-release and pilot builds to evaluate manufacturability, test performance, process capability, and production readiness.
- Develop, qualify, and improve production fixtures, tooling, equipment, and test methods.
- Support supplier selection, ramp-up, and first article inspection, and partner with suppliers to improve quality, capacity, process capability, and manufacturing readiness.
- Sustaining Engineering
- Collaborate with Engineering, Quality, Manufacturing, Supply Chain, and suppliers to resolve production issues, maintain component availability, and sustain product and process performance.
- Apply Lean, Six Sigma, DMAIC, DOE, and statistical methods to reduce waste and variation, improve flow and throughput, and optimize quality and manufacturing cost.
- Troubleshoot electronic assemblies, sensors, instrumentation, production equipment, fixtures, and automated or software-assisted test systems.
- Analyze production and test data to identify root causes of failures, yield loss, process drift, and test variation, and implement effective corrective and preventive actions.
- Quality Assurance
- Develop and execute risk-based process validation activities, including protocols, statistical analyses, acceptance criteria, reports, and ongoing process-capability monitoring.
- Maintain manufacturing processes and documentation in compliance with the company quality management system, ISO 13485, and applicable regulatory requirements.
- General
- Complete required training and follow applicable standard operating procedures and work instructions.
- Maintain regular attendance as an essential job function.
- Protect confidential proprietary information and comply with all company policies and agreements.
- Perform other duties as assigned.
CONTACTS- Internal: Contact with Production, Purchasing, QA/RA, Product Management, Service and Support.
- External: Occasional contact with vendors and consultants.
JOB SPECIFICATIONS- Required Qualifications
- Bachelor's degree in engineering or a related technical discipline, or equivalent relevant experience.
- Minimum of 3 year's experience in Engineering, with consideration of less with an advanced degree.
- Experience in a regulated industry; medical device experience preferred.
- Experience troubleshooting products and manufacturing systems involving sensors, analog and digital circuits, PCB assemblies, instrumentation, electronics manufacturing, or production test.
- Ability to analyze application requirements, evaluate technology and develop innovative solutions to application issues.
- Ability to effectively communicate in English. Excellent written and verbal communication skills.
- Ability to manage multiple tasks with flexible priorities.
- Strong written and verbal communication skills and the ability to manage multiple priorities.
- Preferred Qualifications
- Experience in a regulated manufacturing environment; medical device experience is preferred.
- Experience with process characterization, DOE, capability analysis, and manufacturing or test-process validation.
- Lean or Six Sigma training or certification, including practical use of DMAIC.
- Experience with design for manufacturability or repairability and 3D CAD tools such as SolidWorks.
- Working knowledge of metal fabrication, welding, finishing, plastics molding, electronics manufacturing, or specialized sensor technologies.
WORKING CONDITIONS- Will be required to regularly sit for extended periods of time; use hands and fingers, handle or feel objects, talk, hear and see. Occasionally lift and/or move up to 25 pounds, stand, walk, climb, balance, stoop, kneel, crouch, or reach with hands and arms. The environment is fast-paced; time pressured and requires accuracy. Will be required to regularly multi-task between projects, move throughout the office building and effectively communicate. The normal environment is quiet and typical of an open office setting with some areas that may be louder at times; along with time spent on the production floor, where environment can be louder due to equipment running.
Additional Eligibility QualificationsNone required for this position.
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.
