Development Quality Engineer II
HireMinds is proud to partner with a leader in medical device innovation, focusing on improving healthcare through cutting-edge technology and personalized solutions.
We’re seeking a Dev Quality Engineer II to join the New Product Development team to ensure the quality and safety of their medical devices throughout the product development lifecycle. You’ll work with cross-functional teams to maintain compliance with industry regulations and meet customer expectations.
Key Responsibilities
Collaborate with development teams to implement quality standards
Lead risk management activities, including assessments and mitigation strategies
Review and approve product/process validation activities
Conduct design and process failure mode and effects analysis (DFMEA/PFMEA)
Develop test methods, inspection plans, and quality control procedures
Ensure compliance with FDA, ISO, ITAR, and other relevant standards
Investigate non-conformances and implement corrective actions
Support design teams in addressing quality concerns and improving manufacturability
Assist in supplier quality management and audits
Maintain quality documentation and contribute to regulatory submissions
Qualifications
Bachelor’s degree in engineering (biomedical, mechanical, or related field) or equivalent experience
3-5 years of quality engineering experience, preferably in medical devices
Knowledge of medical device regulations (FDA 21 CFR Part 820, ISO 13485, ISO 14971)
Experience with ITAR-covered parts development
Proficiency in quality tools (FMEA, CAPA, statistical analysis)
Quality certifications (e.g., ASQ Certified Quality Engineer) preferred
Strong problem-solving, analytical, and communication skills
Experience with additive manufacturing is a plus
Benefits
Competitive salary ($75,000 $100,000, based on qualifications and experience)
Annual performance-based bonus
Comprehensive benefits (medical, dental, vision, disability, life, 401k)
Paid time off: Flex Time, Sick Leave, FAMLI Leave, Parental Leave, 9 holidays/year
Educational assistance and supplemental health/life plans
Join us in developing life-saving medical devices in a collaborative, innovative environment with opportunities for professional growth.
