Senior R&D Engineer, Medical Devices - Quality & Compliance

Theuniversityunion; Arden Hills (MN); On-site; USD 100,000 - 140,000; Full time

Job summary

ECI, a leading life sciences consulting firm, seeks a senior Quality/Regulatory professional in Minnesota to drive quality systems, regulatory compliance, and product lifecycle support for medical devices. You will lead design reviews, V&V, and CAPA activities across projects, ensuring FDA and ISO alignment, and mentor teams in advanced statistical methods.

Ideal candidates have extensive experience with cardiac devices, experience with Class III FDA, and strong technical writing skills.

Qualifications

• Minimum 5-6 years’ direct R&D experience in medical device industry.
• Experience with Cardiac Pacemaker, associated monitoring systems and battery, Class III FDA.
• FDA Quality Systems Regulations understanding.
• Knowledge of SPC, DOE, GR&R, CAPA, and process validation.
• Excellent written and verbal communication skills.

Responsibilities

• Provide quality and compliance input to project teams for decisions and deliverables such as Design Change Analysis and Design V&V.
• Develop quality documentation ensuring regulatory, FDA, and ISO compliance.
• Represent Quality initiatives during Design and Phase reviews.
• Lead and collaborate in quality disciplines and decisions.
• Ensure product requirements documentation and conduct quarterly gap analysis.
• Apply statistical sampling techniques and teach advanced statistical methods.
• Direct Acceptance Activities, First Article Inspections, In-Process Inspections, and test plans.
• Support CAPA/NCRs/Complaints and assist on special projects.

Skills

Quality assurance

Regulatory compliance

Statistical methods

Cross-functional teamwork

Documentation

Education

4 Year Degree

Job description

ECI, a leading life sciences consulting firm, seeks a senior Quality/Regulatory professional in Minnesota to drive quality systems, regulatory compliance, and product lifecycle support for medical devices. You will lead design reviews, V&V, and CAPA activities across projects, ensuring FDA and ISO alignment, and mentor teams in advanced statistical methods.

Ideal candidates have extensive experience with cardiac devices, experience with Class III FDA, and strong technical writing skills.