Design Assurance Engineer II – Medical Devices

Bracco Medical Technologies; Eden Prairie (MN); On-site; USD 95,000 - 104,000; Full time

Benefits offered by this job

Paid Time Off

401(k) contributions

Comprehensive medical benefits

Tuition reimbursement

Job summary

Bracco Medical Technologies in Eden Prairie, Minnesota, is looking for a Design Assurance Engineer II to support design assurance activities for medical products. The role demands a strong background in quality engineering, particularly in the medical device industry.

Key responsibilities include managing design control processes, ensuring compliance with regulatory requirements, and leading risk management activities. Candidates should have a B.S. in engineering, along with at least 3 years of relevant experience.

The position offers competitive compensation and a variety of employee benefits to foster growth and well-being.

Qualifications

• 3+ years of Quality Engineering in the medical device industry.
• Advanced knowledge of ISO 13485 and FDA regulations.
• Experience with quality tools like Six Sigma and FMEA.

Responsibilities

• Support design assurance activities for medical devices.
• Drive Design Control process and manage related files.
• Lead risk management activities and ensure compliance.

Skills

Quality Engineering experience

ISO 13485 knowledge

FDA regulations knowledge

Problem solving

Strong communication skills

Education

B.S. in Engineering or Computer Science

Tools

ISO 13485 quality system

Six Sigma

FMEA

Job description

Bracco Medical Technologies in Eden Prairie, Minnesota, is looking for a Design Assurance Engineer II to support design assurance activities for medical products. The role demands a strong background in quality engineering, particularly in the medical device industry.

Key responsibilities include managing design control processes, ensuring compliance with regulatory requirements, and leading risk management activities. Candidates should have a B.S. in engineering, along with at least 3 years of relevant experience.

The position offers competitive compensation and a variety of employee benefits to foster growth and well-being.