4C Medical Technologies, Inc. · 1 day ago
Manufacturing Quality Engineer
Maple Grove,MN,US
Full-time
Onsite
Senior Level
7+ years exp4C Medical Technologies, Inc. is seeking a detail-oriented and collaborative Manufacturing Quality Engineer to support the design, development, and commercialization of transcatheter mitral heart valve technologies. This role is responsible for ensuring compliance with global regulatory and quality requirements and involves leading process validation activities, developing quality assurance policies, and collaborating with cross-functional teams to improve manufacturing processes.
Medical DeviceHealthcareHealth CareMedical
Responsibilities
Lead and execute process validation activities for new and existing manufacturing processes, including installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ)
Lead and execute software validation activities for manufacturing and quality systems, including establishing validation protocols, performing testing, and documenting results
Develops and implements quality assurance policies, procedures, and standards in compliance with ISO 13485:2016
Plan, conduct, and report internal audits per ISO 13485:2016 requirements and company audit schedules
Support nonconformance investigations (NCMRs), CAPA activities, and root cause analysis for manufacturing deviations and process issues
Lead root cause analysis and corrective action initiatives for quality issues
Collaborates with cross-functional teams to improve manufacturing processes and product quality
Analyzes quality data and metrics to identify trends and areas for improvement
Review and approve manufacturing process changes, ensuring compliance with regulatory requirements
Oversee cleanroom qualification and environmental monitoring programs, reviewing reports and ensuring documentation meets ISO 14644 and GMP expectations
Foster a positive culture of growth, collaboration, and achievement across the organization
Provide directions to extended and core team members. Defines, organizes, and manages individual and team tasks
Provide a structured and methodical approach to problem-solving
Work independently with minimal direction in a fast-paced, constantly changing environment
Qualification
Required
Bachelor's degree in Engineering, preferably in Manufacturing, Mechanical, or Industrial Engineering
7+ years of experience in manufacturing quality engineering
Certified Internal Auditor (ISO 13485:2016) or equivalent preferred
Experience with lean manufacturing principles and Six Sigma methodologies
Experience supporting PMA and CE Mark submissions for Class III medical devices
Demonstrated experience with design controls, risk management, DHF documentation, and process/test method validation
Strong knowledge of quality management systems and statistical process control
Demonstrated proficiency in quality management software and data analysis tools
Effective verbal and written communication
Proficiency in technical report writing and review
Interpersonal skills; working in a team and as an individual contributor
Strong understanding of design controls, risk management, statistics, test method validation, and new product development processes
Strong understanding of industry regulations such as ISO13485 and FDA QSR's
Able to handle and be trusted with confidential and/or sensitive information
Able to be flexible and handle multiple projects in an organized, timely manner
Preferred
Certified Internal Auditor (ISO 13485:2016) or equivalent preferred
Company
4C Medical Technologies, Inc.
4C Medical Technologies, Inc.
11-50 employees
Funding
Current Stage
Late StageTotal Funding
$258.5MKey Investors
Boston Scientific,Fu Yuan InvestmentMicroPort CardioFlowYonghua Capital
2025-03-05Series D· $175M
2022-03-31Series C· $35.4M
2020-12-28Convertible Note· $10M
Leadership Team
Saravana Kumar
Chief Executive Officer
Recent News
Google Patent
2025-05-04
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2025-04-02
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