CIVCO Medical Solutions · 7 hours ago
Manufacturing Engineer II
Coralville, IA
Full-time
Onsite
Mid, Senior Level
3+ years expCIVCO Medical Solutions is dedicated to improving healthcare through innovative solutions, and they are seeking a Manufacturing Engineer II to enhance manufacturing processes and product quality. The role involves leading projects, applying Lean and Six Sigma methodologies, and collaborating with cross-functional teams to support new product development and process optimization.
BiotechnologyHealth CareManufacturingMedical Device
Hiring Manager
Emilie Kaufmann
Responsibilities
Serve as the Manufacturing Engineering representative on product development projects, leading design for manufacturability (DFM), packaging selection, and manufacturing process definition
Develop, optimize, and sustain manufacturing processes across form-fill-seal packaging, automation implementation, coagulant dipping, and secondary operations
Analyze manufacturing processes to determine feasibility of in-house production versus outsourcing
Develop cost estimates and support cost reduction initiatives through process optimization, automation, tooling improvements, and waste elimination
Maintain technical ownership of assigned processes and equipment, including troubleshooting, continuous improvement, and performance monitoring
Identify and implement continuous improvement opportunities using Lean Manufacturing and Six Sigma tools
Apply structured problem-solving methodologies to resolve complex manufacturing and quality issues
Optimize process parameters, tooling designs, and equipment utilization to improve capacity, quality, and efficiency
Support automation initiatives by evaluating, piloting, and implementing equipment upgrades, robotics, vision systems, and process controls
Collaborate with design, quality, sourcing, and project engineering teams to support successful new product launches
Lead or support the development of robust manufacturing processes for new products, including pilot builds and scale-up activities
Execute technology transfer activities for new and existing processes to internal manufacturing and qualified external suppliers
Coordinate and execute process validations and equipment qualifications (IQ/OQ/PQ) for new and existing manufacturing processes and equipment
Generate, update, and maintain quality system documentation including SOPs, work instructions, validation protocols and reports
Ensure compliance with ISO 13485, FDA, and other applicable regulatory and quality system requirements
Participate in MRB, change control, and continuous improvement activities as a manufacturing engineering stakeholder
Support capital equipment projects by developing business justifications, technical specifications, and vendor requirements
Lead or co-lead capital equipment installation, commissioning, and qualification activities for assigned projects
Work with suppliers and vendors to ensure proper equipment design, delivery, and integration into production
Support the qualification and technology transfer of CIVCO manufacturing processes to external suppliers
Collaborate with sourcing and quality teams to define and implement product and process requirements for suppliers
Support supplier troubleshooting, process improvements, and ongoing performance monitoring
Identify and evaluate materials and processing methods including injection molding, cutting, sealing, bonding, punching, die-cutting, assembly, sterile packaging, biocompatibility, and shelf-life considerations
Collaborate with Quality Engineering to ensure regulatory compliance of materials and processes
Plan, schedule, and lead department-level and cross-functional projects within defined scope, timeline, and budget
Communicate effectively with internal stakeholders regarding manufacturing performance, improvement initiatives, and project status
Provide technical guidance to technicians, operators, and tooling resources as needed
Maintain working knowledge of new and existing manufacturing technologies, materials, and equipment
Participate in relevant training and professional development opportunities
Stay current with industry best practices and emerging manufacturing technologies
Qualification
Required
Bachelor's degree in mechanical engineering, manufacturing Engineering, industrial Engineering, or related field
3–8 years of manufacturing engineering experience, preferably in a regulated medical device environment
Strong technical problem-solving and analytical skills
Demonstrated ability to lead projects and influence cross-functional teams without direct authority
Proficient in Microsoft Office Suite; CAD experience required
Effective verbal and written communication skills, including the ability to present to small and large groups
Demonstrated leadership behaviors including decision making, collaboration, and conflict resolution
Preferred
Experience with form-fill-seal packaging, automation, coagulant dipping, strongly preferred
Experience working within ISO 9001 preferred; ISO 13485, and FDA
Lean Six Sigma training or certification a plus
Company
CIVCO Medical Solutions
CIVCO Medical Solutions has over 35 years of experience offering cutting-edge medical technology to a diverse group of medical professionals.
201-500 employees
Funding
Current Stage
Growth StageCompany data provided by crunchbase