Senior Quality Engineer

If you’re inspired by improving lives, driven by innovation, and motivated to solve meaningful challenges, there’s a place for you at Senseonics.

Senseonics is a medical technology company dedicated to transforming diabetes management through long-term, implantable continuous glucose monitoring (CGM) systems. Our team is united by a shared mission: delivering life-changing technology that empowers people with diabetes and the healthcare professionals who care for them.

At Senseonics, we put our customers first, challenge ourselves to innovate boldly, and embrace learning as we push the boundaries of what’s possible. We work with urgency, take ownership of our results, and collaborate as one team to deliver solutions that make a real difference.

Working at Senseonics is more than a job, it’s an opportunity to help transform lives.

Job Summary:

The Senior Quality Engineer will be responsible for leading the documentation, oversight and direct support of technical evaluations and investigational tasks required for complaint processing/closure in a timely manner and in accordance with Senseonics procedures and regulatory requirements, with a primary emphasis on US regulatory reporting requirements (FDA MDR, 21 CFR 820/803). This role requires cross-functional collaboration with Regulatory, Clinical, Engineering, Manufacturing, Sales, Customer Support, and other functional experts as needed to ensure clear understanding/investigation of applicable issues.

The Senior Quality Engineer will play a key role in ensuring compliance, driving complaint documentation and investigation quality, and supporting continuous improvement within the complaint handling process. Experience with EU regulatory reporting (Medical Device Vigilance, (EU) 2017/745) is highly valued.

Responsibilities:

• Review and evaluate all feedback received by Senseonics to determine whether it constitutes a customer complaint. Assess each complaint for reportability in accordance with applicable global regulations.
• Responsible for processing complaints and incident reports for submission (MDR and Vigilance) to assure timely, accurate, and complete documentation, investigation, reporting, and formal closure in accordance with regulatory requirements.
• Establish and maintain complaint files and databases for all customer complaints in accordance with U.S. and international regulations.
• Coordinate with Customer Service, Engineering, Quality, and any complaint investigation and analysis personnel to gather root cause determinations and properly document complaint closure.
• Interpret and understand failure modes and root causes of various types of complaints, including device malfunctions and use errors, and appropriately link them to risk IDs in the risk management files.
• Conduct monthly trending and analysis of complaints and failure modes, including calculation of occurrence ratings and assignment of risk ratings.
• Possible involvement with and/or support of internal and external audits of activities related to handling and documenting customer complaints.
• Maintain an understanding of information/data required to be collected for technical and adverse event complaints to assure compliance with regulations and directives.

Qualifications:

• Bachelors in Engineering or a Scientific field desired.
• Extensive knowledge of 21 CFR 820, 21 CFR 803, medical device MDR reporting. Working knowledge of EU regulations (EU 2017/745), ISO-13485, ISO-14971.
• Strong background in US-based medical device adverse event reporting to FDA; EU reporting (Vigilance) experience is beneficial.
• Excellent technical writing skills, with ability to translate complex investigations into clear, concise documentation for both technical and non-technical audiences.
• Excellent computer skills, including Outlook, Word, Excel, and Powerpoint
• Experience in a GMP and/or ISO regulated medical device environment is preferred.
• 4-6+ years of experience in a medical device complaint handling documentation & processing preferred.
• Proven ability to work effectively in a cross-functional team environment.
• Highly developed verbal, written, and interpersonal communication skills.
• Ability to organize tasks, work independently and adapt to changing priorities.
• Strong ability to manage and organize large datasets, efficiently summarize key findings, and identify trends or issues that require escalation.
• Ability to function in a minimally supervised environment with exceptional attention to detail required
• Commitment to meeting business needs, including flexibility to work extended hours or outside business hours as required.