Senior R&D Engineer - Medical Device #7920

ECI; Quebec; On-site; CAD 90,000 - 120,000; Full time

Job summary

ECI in Canada seeks a Quality Assurance leader to guide design controls, risk management and regulatory compliance for medical device projects. You will partner with R&D and operations to ensure products meet FDA/ISO standards and customer requirements throughout development.

The role demands hands-on quality engineering, robust documentation, CAPA handling, and continuous improvement. You will mentor teams, drive verification activities, and implement sampling, DOE, and GR&R methods to uphold

Qualifications

• Experience in quality engineering for medical devices and life sciences projects.
• Familiarity with FDA/ISO regulatory requirements and quality systems.
• Strong communication and collaboration skills in cross-functional teams.
• Ability to lead quality initiatives across design, development, and manufacturing.

Responsibilities

• Provide quality and compliance input to project teams for decisions and deliverables.
• Develop quality documentation such as quality plans, SOPs, and inspection procedures; ensure regulatory, FDA, and ISO compliance.
• Represent Quality initiatives and compliance during Design and Phase reviews.
• Lead quality disciplines and support CAPA/NCRs/Complaints.
• Ensure product requirements are documented and verification reviewed.
• Teach statistical sampling techniques and DOE/ANOVA methods.
• Provide direction for Acceptance Activities, In-Process Inspections and sampling plans.
• Apply systematic problem-solving methodologies to resolve quality issues.
• Assist in special projects as needed.

Skills

Quality engineering

Regulatory compliance

Medical devices

R&D experience

Education

Bachelor's degree in engineering

Job 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.

Brief 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.

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 project as needed or requested

What We Look For

• Bachelor’s degree in engineering or equivalent work experience


• 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.