Senior R&D Engineer - Medical Device #9058

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

• Employee Type Contractor or FT Employee
• Required Degree 4 Year Degree

Description

About ECI

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 proj ect 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 t echnical 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.