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Tier-1 employer and metro mid-level role create moderate applicant competition.
Requires medical-device regulatory and IEC standard expertise, making cross-industry transferability low.
Explicit 5-7 years, mandatory medical device standards and regulated quality requirements increase filter strictness.
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Own and guide the implementation of process validation and design control processes to ensure new medical device products transition effectively and comply with regulatory standards.
Review and improve quality engineering documents and plans for hardware, software, and system designs including quality, reliability, and Post Market Surveillance integration.
Drive root cause analysis, risk management, post-market analytics, and continuous improvement initiatives to maintain product quality and readiness for audits and inspections.
Bachelor's degree in Mechanical Engineering, Electronics Engineering, Science, or equivalent.
5-7 years of experience in Quality Engineering, Safety Engineering, or R&D Engineering with hardware and software product exposure.
Mandatory experience with IEC 62304/82304 standards.
Six Sigma Green Belt certification preferred but not mandatory.
Experienced in medical device R&D, quality, or safety environments with 5-8 years preferred.
Proficient in applying design quality management, data analysis, root cause analysis, CAPA methodologies, and regulatory compliance in complex product cycles.
Comfortable working onsite at least 3 days per week as part of a collaborative, office-based team environment.