Contract Medical Device Design Jobs in Missouri (NOW HIRING)

• Support new hardware and software medical device product development
• Support sustaining product line activities and hardware customer quality activities
• Serve as Design Quality Project Lead for cross-functional teams
• Advise teams on design controls, cybersecurity, AI/ML-enabled medical device considerations, risk management, human factors and usability engineering, verification and validation, and mitigations
• Communicate quality metrics to promote continual improvement and compliance with QMS procedures, laws, regulations, standards, and guidance
• Develop, establish, and maintain design controls, quality engineering methodologies, systems, and practices
• Interact with R&D, Program Management, Manufacturing Operations and Engineering, Quality Management Systems, Regulatory, Clinical, Marketing, customer-facing teams, and customers as appropriate
• Support regulatory, notified body, FDA, internal, customer, supplier, and contract manufacturer audits
• Support customer issue resolution and cross-functional product quality activities

Requirements

• Bachelor's degree in engineering, life sciences, biomedical engineering, mechanical engineering, electrical engineering, software engineering, quality, or a related technical field
• Experience in design quality engineering, quality engineering, product development, systems engineering, software quality, AI/ML quality, hardware quality, or a related role in a regulated industry
• Experience with AI/ML-enabled medical devices, software-enabled medical devices, SaMD, clinical decision support tools, diagnostic algorithms, imaging algorithms, predictive models, or other regulated AI/ML product development
• Strong working knowledge of medical device design controls
• Experience owning or maintaining medical device risk management files in accordance with ISO 14971
• Strong proficiency with 8D problem-solving tools and methods
• Ability to understand technical details related to customer complaints, quality issues, hardware failures, manufacturing escapes, and product risk
• Knowledge of AI/ML development and validation considerations
• Knowledge of human factors and usability engineering principles, including IEC 62366
• Experience with SMT, PCBA, semiconductor manufacturing, electronics manufacturing, supplier manufacturing controls, or contract manufacturer quality
• Familiarity with cybersecurity expectations for connected medical devices
• Familiarity with IEC 60601 electrical safety testing requirements
• Familiarity with FDA 21 CFR Part 820 and ISO 13485
• Strong written and oral communication skills
• Strong cross-functional leadership and coordination skills
• Ability to design, iterate, and optimize complex prompts for AI models
• Candidates must be authorized to work in the United States; no immigration sponsorship is provided
• Preferred/ideal qualifications include Class II or Class III medical device experience, additional standards knowledge, eQMS/PLM experience, CAPA and complaint investigation experience, and ASQ, Six Sigma, or RAC certification

Core Competencies

Demonstrates expertise in design quality engineering and risk management for medical devices, with a strong focus on AI/ML-enabled products and compliance with regulatory standards. Proficient in cross-functional collaboration and quality improvement methodologies to ensure product excellence.

Highest-signal resume keywords

• Design Quality Engineering
• Medical Device Risk Management
• AI/ML-Enabled Medical Devices
• Quality Management Systems Compliance
• Cross-Functional Leadership

ATS Optimization Keywords Hard Skills

• Design Controls
• Quality Engineering Methodologies
• 8D Problem-Solving Tools
• Human Factors Engineering
• Usability Engineering
• ISO 14971 Compliance
• IEC 62366 Knowledge
• FDA 21 CFR Part 820 Familiarity
• ISO 13485 Familiarity
• AI Model Optimization

Soft Skills

• Strong Written Communication
• Strong Oral Communication
• Cross-Functional Coordination

Certifications & Qualifications

• ASQ Certification
• Six Sigma Certification
• RAC Certification

Industry Keywords

• Medical Device Development
• Regulated Industry Experience
• Clinical Decision Support Tools
• Diagnostic Algorithms
• Predictive Models
• Electronics Manufacturing
• Supplier Manufacturing Controls
• Connected Medical Devices
• Electrical Safety Testing
• Contract Manufacturer Quality

Tools & Technologies

• EQMS
• PLM
• CAPA
• Complaint Investigation Tools
• Cybersecurity Standards