Complaints Engineer II

Complaints Engineer II

Date:
Aug 4, 2026

Req

Location:

Elkton, MD, US

Company:
Terumo Medical Corporation

Department:
Post Market Surveillance

Terumo Medical Corporation (TMC) develops, manufactures, and markets a complete, solutions-based portfolio of high-quality medical devices used in a broad range of applications for numerous areas of the healthcare industry. TMC places a premium on providing customers with world-class products, training and education programs that drive clear economic value, better clinical outcomes and improved quality of life for patients. TMC is part of Tokyo-based Terumo Corporation;

one of the world's leading medical device manufacturers with $6+ billion in sales, 30,000+ employees worldwide and operations in more than 160 nations. Terumo Medical Corporation is comprised of two strategic business divisions:
Terumo Interventional Systems and Terumo Medical Products.

We believe that the future is bright for everyone  work with the future in mind to generate lasting change, create a bigger impact and produce greater outcomes for today, and for decades to come.

At Terumo we believe in the power of personal growth and will encourage you to get in the driver's seat - progressing in the direction you want to go by deepening your skills throughout your career. We want you to be bold, think outside the box, experiment, innovate and deliver what's next for quality healthcare. You will be part of a collaborative, respectful and resilient team of associates and leaders around the world, working together as partners to achieve more than you thought possible, providing real-world, impactful solutions for patients.

Join us and help shape wherever we go next!

Advancing healthcare with heart

The Complaints Engineer II is responsible for analyses, evaluation and product investigation of complaints received from external customers with respect to business objectives and in compliance with Food and Drug Administration (FDA), International Standards Organization (ISO), Quality System Requirements (QSR), EU MDR, and other regulatory guidelines. Drives all complaint investigation activities with cross functional team members and prepares complaint investigation reports, assigns test on retention, and returned samples and writes customer letters.

Assists the Team Lead or Manager to improve complaints and post market processes and procedures to generate efficiencies.

The Complaints Engineer II provides support, assistance, and training for team members under guidance and direction of the Team Lead/Manager with regards to the overall complaints engineering process. Responsible for engineering evaluation of returned products and trending analysis, in accordance with Terumo Medical Corporation procedures, and regulatory requirements. The Complaints Engineer II will interact with medical professionals, marketing, customers, customer service, clinical, regulatory, R&D and management to support in the complaint investigation process.

• 1. Promotes a work environment of continuous improvement that supports Terumo Quality Policy, Quality System, and the appropriate regulations.
• 2. Accountable for compliance with applicable US and International regulations and directives; including, but not limited to Food & Drug Administration (FDA), Canadian and European Union Medical Device Regulations (EU MDR) regulations governing adverse event reports such as Medical Device Reports (MDR) and Medical Device Vigilance (MDV).
• 3. Works with the adverse event reporting group and the complaints intake group to ensure accurate, and timely generation of Medical Device Reports (MDRs) and Vigilance Reports as required.
• 4. Responsible for compilation of Post Market Safety Update Reports (PSUR) required per EU MDR for the assigned product lines or as directed by the Manager.
• 5. Ensure that the team and organizational key performance indicators and metric targets are achieved and sustained by successfully collaborating with all parts of the PMSV function and where needed, greater QA function.
• 6. Collecting timely follow up information related to complaints from customers; typically, through the Sales and/or Field Service groups. This includes interactions with appropriate stakeholders including but not limited to customers, medical professionals, field staff and Terumo affiliates to obtain information pertinent to investigations.
• 7. Collaborate in assessing Adverse Event Reportability decisions in accordance with US and International regulations.
• 8. Act as Post Market Surveillance Subject Matter Expert for assigned product lines which includes having expert knowledge about product design, manufacturing, complaint rates, complaint trends, reportability, risk and failure modes.
• 9. Responsible for driving all complaint investigation activities with cross functional team members, prepares complaint investigation reports, conducts objective testing an