Remote Senior Design Quality Engineer, Medical Devices

ECI; Arden Hills (MN); Remote; USD 110,000 - 160,000; Full time

Job summary

ECI is seeking a quality-focused professional for a remote role in the life sciences space. The work centers on a design control gap assessment and providing quality and regulatory input across project teams during decisions and deliverables.

Responsibilities include developing quality documentation, leading design reviews, and ensuring FDA/ISO compliance throughout product development. Strong communication and collaboration are essential for success in this role.

Qualifications

• Bachelor's degree in engineering or equivalent work experience.
• 5-10 years' direct R&D experience in medical device industry.
• Experience in ops quality and design quality.
• Excellent written and verbal communication skills.
• Collaborative attitude with the ability to work well in a team environment.
• Strong engineering, design, and analysis skills with medical devices from concept to commercialization.
• Understanding of FDA Quality Systems Regulations.
• Demonstrated use of quality tools including SPC, DOE, GR&R, FMEA, CAPA, and process validation.
• Knowledge of FDA 21CFR820, ISO 13485, 14971, and 11607 standards.

Responsibilities

• The major task is a design control gap assessment.
• Provide input on design inputs/requirements and risk management.
• Support project teams with decisions and deliverables (e.g., Design Change Analysis, Design Inputs/Outputs, Test Methods, Design Review, Design V&V, Usability Testing, Process Validation, Labeling).
• Develop quality documentation such as quality plans, SOPs, and inspection procedures; ensure FDA/ISO compliance.
• Represent Quality initiatives during Design and Phase reviews and lead quality discussions.
• Lead and collaborate on quality disciplines and decision-making practices.
• Document product requirements (PR) and perform quarterly gap analyses; review verification docs.
• Teach statistically valid sampling and advanced statistics (DOE, etc.).
• Direct Acceptance Activities, First Article Inspections, In-Process Inspections, Sampling Plans and testing.
• Apply systematic problem-solving to identify, prioritize, and resolve quality issues.
• Provide support for CAPA/NCRs/Complaints and assist with special projects.

Skills

Quality systems

Quality documentation

Regulatory knowledge

Statistical methods

Education

Bachelor's degree in engineering

Tools

DOE

SPC

GR&R

FMEA

CAPA

Process validation

IQ/OQ/PQ

Job description

ECI is seeking a quality-focused professional for a remote role in the life sciences space. The work centers on a design control gap assessment and providing quality and regulatory input across project teams during decisions and deliverables.

Responsibilities include developing quality documentation, leading design reviews, and ensuring FDA/ISO compliance throughout product development. Strong communication and collaboration are essential for success in this role.