Reliability Engineer II

What you'll do

• Lead technical evaluations of field-observed product performance and conduct risk assessments aligned with management files.
• Analyze complaint data, software performance, hardware reliability, and product trends to identify improvement opportunities.
• Partner with Medical Safety to assess potential patient harm and evaluate overall product risk.
• Evaluate the reliability and risk impact of design, manufacturing, supplier, and software changes for released products.
• Serve as the technical representative for post-market quality processes, including Corrective and Preventive Actions (CAPA).
• Develop data-driven recommendations to improve product reliability, patient safety, and long-term performance.
• Support post-market risk evaluations regarding containment actions, product corrections, field actions, and recalls.
• Shape and improve post-market reliability strategies, processes, and risk management practices.

What we're looking for

• Applicants must have a Baccalaureate degree and at least 2 years of relevant experience, or a Master’s degree with no minimum experience required.
• Experience supporting post-market quality, reliability engineering, or product performance for regulated medical devices is preferred.
• Knowledge of medical device risk management methodologies, including ISO 14971, is preferred.
• Experience investigating product complaints, field issues, and CAPA activities is preferred.
• Strong analytical skills using statistical methods to evaluate product reliability and performance trends are required.
• Ability to interpret hardware, firmware, and software performance data to support technical investigations is required.
• Experience authoring technical reports and engineering assessments in a regulated environment is required.
• Work authorization at the time of hire and for the duration of employment.