R&D Quality Engineer II - Medical Devices

Midmark Corporation; Versailles (OH); Sur place; USD 80 000 - 110 000; Plein temps

Résumé du poste

Midmark Corporation seeks an R&D Quality Engineer II to lead quality initiatives across new product development, ensuring robust design and manufacturability of medical devices. You will participate in risk assessments, documentation, and continuous improvement using Six Sigma tools.

Ideal candidates have a engineering degree, 2+ years of relevant experience, and strong analytical and communication skills to mentor junior engineers and work with cross-functional teams in a regulated environment.

Qualifications

• Bachelor's degree in engineering or related field with 2+ years of experience.
• Six Sigma Black Belt certification preferred.
• Strong MS Office and Minitab proficiency.
• Excellent communication and analytical problem-solving.

Responsabilités

• Lead quality deliverables on NPD projects per ISO/FDA regulations.
• Assist with safety risk management and risk documentation.
• Create/review PRP-related documentation (change requests, test specs, design records).
• Facilitate FMEA process and drive process improvements using Six Sigma.
• Mentor/co-op and engineer I teammates; collaborate with cross-functional teams.

Connaissances

Quality engineering

Risk management

FMEA

Six Sigma

Data analysis

Cross-functional

Formation

Bachelor's degree in engineering

Six Sigma Black Belt preferred

Description du poste

Midmark Corporation seeks an R&D Quality Engineer II to lead quality initiatives across new product development, ensuring robust design and manufacturability of medical devices. You will participate in risk assessments, documentation, and continuous improvement using Six Sigma tools.

Ideal candidates have a engineering degree, 2+ years of relevant experience, and strong analytical and communication skills to mentor junior engineers and work with cross-functional teams in a regulated environment.