Strong knowledge of statistics and minitab software
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Integer is seeking a Senior Engineer for New Product Introduction (NPI) who will apply advanced engineering principles to ensure high-quality product development and compliance with regulatory standards. The ideal candidate should possess extensive experience in engineering roles, strong problem-solving skills, and a collaborative spirit aligned with Integer's core values.
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Job Summary
This role involves applying intensive engineering knowledge to ensure New Product Introduction projects meet quality standards for medical device OEMs.
The engineer will lead test method development, validation, and root cause analysis while ensuring compliance with FDA regulations and ISO standards.
Candidates are expected to mentor other engineers, support continuous improvement initiatives, and drive the organization towards 5 Sigma quality goals.
Matching Summary
Match Score: 75
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Integer is seeking a Senior Engineer for New Product Introduction (NPI) who will apply advanced engineering principles to ensure high-quality product development and compliance with regulatory standards. The ideal candidate should possess extensive experience in engineering roles, strong problem-solving skills, and a collaborative spirit aligned with Integer's core values.
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Skills & Requirements
Must-have
Bachelor's degree in engineering or related field
7+ years of progressive engineering experience
Strong knowledge of statistics and Minitab software
Experience with ISO14971 risk management
Knowledge of FDA regulations and QMS
Nice-to-have
Master's degree in engineering
Six Sigma Black Belt certification
Leadership experience managing direct reports
Mentoring and coaching capabilities
Cross-functional project team leadership
Key Requirements
Minimum Bachelor's degree in engineering
7+ years of relevant engineering experience
Six Sigma Green Belt required, Black Belt preferred
US work authorization implied by Equal Opportunity Employer statement