Senior R&D Engineer - Medical Device-Cardiac #9058

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’s mission is to be the global leader of professional consulting services for the life sciences industry. Our clients lean on our diverse perspectives and decades of expertise to tackle their toughest challenges, and we take pride in providing them with transformative solutions with distinctive, sustainable and long-term value. ECI boasts a proven track record of providing full product life cycle consulting on a variety of challenging and exciting projects. Our collaborative culture, welcoming team and flexible employment & benefit options allow us to maintain strong relationships with the most talented individuals in the life sciences industry.

What You’ll Do

• Provide quality and compliance input to project teams for decisions and deliverables (e.g., Design Change Analysis, Design Inputs, Design Outputs, Test Methods, Design Review, Design V&V, Usability Testing, Process Validation, and Labeling)
• Develop quality documentation such as quality plans, standard operating procedures, and inspection procedures. Ensure regulatory, FDA, and ISO compliance in all areas of responsibilities
• Represent Quality initiatives and compliance when participating and Design and Phase reviews
• Serve as an effective leader and team member in supporting quality disciplines, decisions, and practices
• Ensure that required standards for products are documented in the product requirements (PR) specification and ensure compliance by performing quarterly gap analysis and reviewing applicable verification documentation
• Ensure the use of statistically valid sampling techniques and teach others on the use of these and other advanced statistical techniques such as DOE and ANOVA evaluations
• Provide direction and lead the implementation of Acceptance Activities, First Article Inspections, In-Process Inspections, Sampling Plans, product/component testing, inspections, and acceptance criteria
• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• Provide support for CAPA/NCRs/Complaints
• Assist in special project as needed or requested

What We Look For

• Minimum of 5-6 years’ direct R&D experience in medical device industry working with electromechanical devices
• Prior experience working with Cardiac Pacemaker, associated monitoring systems and battery, Class III FDA
• Experience with durable medical capital equipment in addition to single-use devices is preferred
• Excellent written and verbal communication skills with good presentation and technical writing skills
• Collaborative attitude with the ability to work well in a team environment
• Strong engineering, design, and analysis skills along with experience with medical devices from concept to commercialization
• Understanding of FDA Quality Systems Regulations
• Demonstrated use of quality tools and methodologies including SPC, DOE, GR&R, FMEA, CAPA, and process validation (IQ, OQ/PQ)
• Must have a good understanding of FDA 21CFR820, ISO 13485, 14971, and 11607 standards

ECI is an equal opportunity employer.

All qualified applicants will receive consideration for employment at ECI without regard to race; creed; color; religion; national origin; sex; age; disability; sexual orientation; gender identity or expression; genetic predisposition or carrier status; veteran, marital, or citizenship status; or any other status protected by law.