MedTech Design Assurance Leader

MicroTransponder; Fridley (MN); On-site; USD 110,000 - 160,000; Full time

Benefits offered by this job

Medical, dental and vision plans

401(k) with company match

Unlimited PTO

18 holidays per year

Job summary

Mobia Medical seeks a Principal Design Assurance Engineer to lead hardware and electrical medical device design assurance across development stages. You will bridge Design Engineering and Quality, ensure DHF maintenance, and guide risk management and regulatory compliance.

The role requires 10+ years in regulated environments, expertise in design controls, V&V, and strong communication. Candidates should be adept at investigations, CAPA, audits, and cross-functional collaboration.

Qualifications

• Bachelor’s degree in Electrical, Biomedical, Mechanical Engineering, or related field with 10+ years of progressive experience.
• Experience applying hardware and electrical design controls in regulated industries.
• Quality engineering experience or certification preferred.
• Strong knowledge of DHF maintenance, verification and validation testing, and test method development.
• Knowledge of FDA 21 CFR Part 820, ISO 13485, ISO 14971, IEC 60601, IEC 61010, ISO 10993, EU MDR.

Responsibilities

• Provide Design Assurance leadership throughout the design and development of new hardware and electrical medical device products.
• Support post-market sustaining activities including failure analysis, design change development and implementation, supplier evaluation, certifications, complaint investigations, and nonconformance disposition.
• Lead root cause investigations, corrective action development, and verification of effectiveness.
• Lead and support compliant development, verification, validation, and transfer of new products and processes into manufacturing.
• Serve as a subject matter expert in hardware and electrical design controls, risk management, verification & validation, and DHF maintenance.
• Support new process development, test method development and validation, process characterization, and technical investigations.
• Lead and participate in design verification and validation activities with clear documentation.
• Ensure hardware and electrical designs meet regulatory and company standards for quality, safety, performance, and reliability.

Skills

Electrical Engineering

Biomedical Engineering

Mechanical Engineering

Regulatory Compliance

Education

Bachelor’s degree in Electrical, Biomedical, Mechanical Engineering, or related field

Job description

Mobia Medical seeks a Principal Design Assurance Engineer to lead hardware and electrical medical device design assurance across development stages. You will bridge Design Engineering and Quality, ensure DHF maintenance, and guide risk management and regulatory compliance.

The role requires 10+ years in regulated environments, expertise in design controls, V&V, and strong communication. Candidates should be adept at investigations, CAPA, audits, and cross-functional collaboration.