Manufacturing Engineer II
About the role
Cirtec Medical is a leading outsourcing partner for complex medical devices, specializing in Class II and III devices. We focus on design and development, precision components, and finished device assembly for various medical devices including neuromodulation, implantable drug delivery, cardiac rhythm management, structural heart, mechanical circulatory support, and minimally invasive surgical systems.
Key Responsibilities
Develops and implements robust cost-effective manufacturing processes and improves product flow and product quality and safety performance for both sustained and new products.
Leads design transfer of new products to production; including establishing assembly time and yield targets, training needs, and quality control.
Develops tests, implements tools, fixtures, and equipment required for manufacturing processes.
Develops manufacturing process instructions, inspection plans, and lot history travelers.
Led creation of manufacturing process validation plans, validation protocols, and reports, and implements manufacturing process validations and test method validations.
Collaborates with cross-functional teams during development phase(s) and provides inputs and recommendations for design for manufacturability (DFM).
Develops and maintains process risk documentation (e.g., PFMEA) to identify potential risks and implement preventive and corrective actions.
Manages and/or supports production and test equipment maintenance qualification and calibration.
Performs analysis for cost reduction, quality, and efficiency improvement.
Prepares engineering change orders (ECOs) and coordinates the implementation of changes including training production staff.
Troubleshoots designs and processes when defects occur, leads investigation to determine root cause and implements effective containment and counter measures.
Disposes non-conforming products and develops required re-work procedures.
Communicates with customers regarding process improvements and production changes.
Qualifications
BS in Mechanical / Biomedical / Industrial Engineering or an equivalent engineering (STEM) discipline required.
2+ years of experience in medical device process development and/or manufacturing engineering.
Experience with new product introduction (NPI).
Solid knowledge of GMP and ISO 13485 regulations.
Must be able to review and interpret technical drawings and specifications.
Strong computer skills including the MS Office suite.
Must be able to read, write, and speak fluent English and must possess excellent communication skills, both written and oral.
Demonstrated organizational skills to manage multiple priorities and schedules.
Good to have:
Experience with lean manufacturing techniques, value stream mapping, and continuous improvement methodologies.
Proficiency in SolidWorks.
Experience working directly with catheters.
Benefits
Cirtec Medical offers a wide range of benefits, including Training and career development, Healthcare and well-being programs, including medical, dental, vision, wellness and occupational health programs, Paid Time Off, and a 401(k) retirement savings plan with a company match.