Description

Description

Under general supervision, designs, transfers and improves manufacturing processes by implementing equipment and tooling, adhering to precise product specifications and quality standards within a collaborative engineering team. Furthermore, this position conducts thorough analyses of both the design and manufacturing processes, focusing on enhancing producibility, quality, and cost-effectiveness for both existing and new products.

Responsibilities

• Design precision tools and fixtures for medical device production, both within and outside clean room environments.
• Initiate improvement projects for existing tooling and fixtures in collaboration with manufacturing teams.
• Analyze and resolve production issues efficiently.
• Author, conduct, and analyze engineering experiments in support of equipment design, and qualifications.
• Write test protocols and test reports for IQ, OQ, and PQ activities.
• Execute products transfer and validation OQ/PQ/PPQ
• Robust statistical analysis (PPK/Cpk/Tolerance intervals/Normality/Capacity analysis 
• Conduct economic analyses and calculate return on investment to substantiate new equipment investments.
• Analyze and resolve production issues efficiently. 
• Robust skills in DMAIC/PDCA/Lean Six Sigma methodologies
• Strategically aim for and implement cost-saving measures.
• Perform additional duties as assigned

Qualification

• Proficient in hands-on mechanical design using SolidWorks for precise engineering desirable.
• Specialized in medical device manufacturing equipment and processes, ensuring expertise in industry-specific standards.
• Familiarity with industrial machine control concepts, encompassing motors, sensors, and other related electrical components.
• Familiarity with products transfer validations
• Conducts production method analyses and offers proposals for enhancing or introducing new manufacturing processes.
• Skilled in adhering to FDA ISO 13485 and 21 CFR, part 820 requirements for regulatory compliance.
• Effective in presenting engineering investigations and findings to management, showcasing strong communication and presentation abilities.
• Familiar with engineering statistical analysis, DOE, Process Capability, and similar methodologies using Minitab software, ensuring data-driven decisions.
• Bachelor’s degree in Mechanical/Electrical/Electronic/Industrial Engineering, or other related field.
• Minimum 3 years of experience in similar role
• Master's degree in engineering related role

Inari Medical, Inc. advises applicants that employment is subject to completion of a successful background check.