Integer is seeking a Senior Engineer for New Product Introduction (NPI) who will leverage engineering principles to support the development and validation of medical devices and specialized battery technologies. The ideal candidate will have a strong technical background, particularly in quality management and problem-solving methodologies, to ensure compliance with regulatory standards
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 validations, root cause analyses, and continuous improvement projects while adhering to FDA and ISO regulations.
Candidates are expected to mentor others, manage cross-functional teams, and drive the organization's journey toward 5 Sigma quality metrics.
Matching Summary
Match Score: 85
Integer is seeking a Senior Engineer for New Product Introduction (NPI) who will leverage engineering principles to support the development and validation of medical devices and specialized battery technologies. The ideal candidate will have a strong technical background, particularly in quality management and problem-solving methodologies, to ensure compliance with regulatory standards.
Skills & Requirements
Must-have
Bachelor's degree in engineering
7+ years progressive engineering experience
Six Sigma Green Belt certification minimum
Minitab statistical analysis software
ISO14971 risk management knowledge
FDA regulations and QMS compliance
Root cause analysis and CAPA leadership
Nice-to-have
Master's degree in engineering field
Six Sigma Black Belt certification
Experience mentoring junior engineers
Cross-functional team leadership skills
5 Sigma quality journey participation
Supplier quality capability studies
Positive can-do attitude under pressure
Key Requirements
Minimum Bachelor's degree in engineering or related field
7+ years of progressive engineering experience
Six Sigma Green Belt certification required
Strong working knowledge of statistics and Minitab