Senior R&D Engineer, Medical Devices — Quality & Regulatory Lead

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

Job summary

ECI seeks a Quality & Regulatory professional in Minnesota to provide quality and compliance input to project teams, support design outputs, V&V, and labeling, ensuring FDA/ISO compliance across the product lifecycle.

You will develop quality documentation, lead quality initiatives during design reviews, and guide effective CAPA processes while collaborating with engineering, manufacturing, and operations to bring safe medical devices from concept to commercialization.

Qualifications

• Bachelor's degree in engineering or equivalent work experience.
• Minimum 5-6 years' direct R&D experience in medical devices.
• Experience with durable medical capital equipment and single-use devices preferred.
• Excellent written and verbal communication with strong technical writing skills.
• Collaborative attitude and ability to work in a team.
• Strong engineering, design and analysis skills for concepts to commercialization.
• Understanding of FDA Quality Systems Regulations.
• Familiarity with quality tools: SPC, DOE, GR&R, FMEA, CAPA, and process validation.

Responsibilities

• Provide quality and compliance input to project teams for decisions and deliverables.
• Develop quality documentation such as quality plans and SOPs; ensure FDA/ISO compliance.
• Represent Quality initiatives during design and phase reviews.
• Lead quality disciplines and support CAPA/ NCRs.
• Ensure product requirements are well documented and checked by gap analysis.
• Apply systematic problem-solving to identify and resolve quality issues.
• Provide support for CAPA/NCRs/Complaints.
• Assist with special projects as needed.

Skills

Communication skills

Team collaboration

Engineering, design and analysis

Education

Bachelor's degree in engineering or equivalent work experience

Tools

SPC

DOE

GR&R

FMEA

CAPA

Process Validation (IQ/OQ/PQ)

Job description

ECI seeks a Quality & Regulatory professional in Minnesota to provide quality and compliance input to project teams, support design outputs, V&V, and labeling, ensuring FDA/ISO compliance across the product lifecycle.

You will develop quality documentation, lead quality initiatives during design reviews, and guide effective CAPA processes while collaborating with engineering, manufacturing, and operations to bring safe medical devices from concept to commercialization.