Senior Medical Device R&D Engineer - Quality & Compliance

ECI; Arden Hills (MN); On-site; USD 90,000 - 140,000; Full time

Job summary

ECI seeks a seasoned Quality Engineer to drive quality and regulatory compliance across design and development of electromechanical medical devices. You will contribute to decisions, document quality plans, and ensure FDA/ISO adherence from concept through validation.

You’ll lead quality initiatives, apply SPC, DOE, and CAPA tools, and mentor teams while collaborating with engineering, manufacturing, and QA to deliver safe, compliant products on schedule.

Qualifications

• 5–6 years’ direct R&D experience in medical devices (electromechanical)
• Experience with Cardiac Pacemaker, monitoring systems, and battery; Class III FDA
• Experience with durable medical capital equipment and single-use devices
• Excellent written and verbal communication; strong technical writing
• Collaborative, team-oriented
• Strong engineering, design, and analysis skills from concept to commercialization
• Understanding of FDA Quality Systems Regulations
• Experience with SPC, DOE, GR&R, FMEA, CAPA, and process validation (IQ, OQ/PQ)
• Familiarity with FDA 21 CFR 820, ISO 13485, 14971, 11607

Responsibilities

• Provide quality and compliance input to project teams for decisions and deliverables
• Develop quality documentation and ensure regulatory, FDA, and ISO compliance
• Represent Quality initiatives during Design and Phase reviews
• Lead quality disciplines and support decisions and practices
• Document product requirements and perform gap analyses and review verification documents
• Apply statistical sampling techniques; teach DOE and ANOVA
• Lead acceptance activities, inspections, and testing
• Use problem-solving methodologies to resolve quality issues
• Support CAPA/NCRs/Complaints
• Assist on special projects as needed

Skills

Quality management

Regulatory compliance

Statistical methods

DOE

FMEA

CAPA

Team leadership

Technical writing

Tools

GR&R

FMEA

SPC

CAPA system

IQ/OQ/PQ

GxP knowledge

Job description

ECI seeks a seasoned Quality Engineer to drive quality and regulatory compliance across design and development of electromechanical medical devices. You will contribute to decisions, document quality plans, and ensure FDA/ISO adherence from concept through validation.

You’ll lead quality initiatives, apply SPC, DOE, and CAPA tools, and mentor teams while collaborating with engineering, manufacturing, and QA to deliver safe, compliant products on schedule.