Senior Complaints Engineer: Post-Market MDR & Investigation Lead

Terumo; Oregon; Hybrid; USD 47,000 - 66,000; Full time

Benefits offered by this job

Annual bonus

Paid vacation

Paid holidays

Health benefits

Dental benefits

Vision benefits

401(k)

Job summary

Terumo Medical Corporation (TMC) is seeking a Complaints Engineer II to lead investigations of customer-reported issues in a regulated environment. You will collaborate with cross-functional teams to evaluate, test, and document product complaints, supporting FDA, ISO, QSR, EU MDR, and other regulatory requirements.

The role requires a 4-year degree in engineering or life sciences and at least three years of related experience, with strong analytical, communication, and data-analysis skills.

Qualifications

• Thorough knowledge of standards and regulations for medical devices.
• Strong analytical and problem-solving skills.
• Excellent written and oral English communication skills; MS Office experience.
• Ability to interact with individuals and groups at all levels.

Responsibilities

• Promote continuous improvement aligning with Terumo Quality Policy and regulatory directives.
• Ensure timely generation of MDRs and Vigilance Reports with relevant groups.
• Contribute to Post Market Safety Updates per EU MDR requirements.
• Lead complaint investigations with cross-functional teams and prepare reports.
• Perform data analysis, testing, and root cause investigations for complaints.
• Present engineering failure analyses at trending meetings and other forums.

Skills

Analytical skills

Problem-solving

English communication

Regulatory knowledge

Education

4-year degree in engineering, life sciences, or equivalent

Tools

MS Office

Minitab

Job description

Terumo Medical Corporation (TMC) is seeking a Complaints Engineer II to lead investigations of customer-reported issues in a regulated environment. You will collaborate with cross-functional teams to evaluate, test, and document product complaints, supporting FDA, ISO, QSR, EU MDR, and other regulatory requirements.

The role requires a 4-year degree in engineering or life sciences and at least three years of related experience, with strong analytical, communication, and data-analysis skills.