$120,450 - $176,660; not specified; comprehensive ...
Iso 14971 risk management
Design verification and validation
Fda quality system regulations
The primary purpose of this job is to support new product development to ensure that the desired design performance is achieved meeting the applicable medical device FDA/European regulatory requirements and companies Policies & Procedures
Job Summary
The primary purpose of this job is to support new product development to ensure that the desired design performance is achieved meeting the applicable medical device FDA/European regulatory requirements and companies Policies & Procedures.
Leads Risk Management (ISO 14971) and Usability program activities, leading cross-function teams in planning, analyses, and mitigations.
Our total rewards program is designed to attract, retain, and motivate associates to contribute to Integer’s success, including a comprehensive benefits package with immediate eligibility.
Matching Summary
The primary purpose of this job is to support new product development to ensure that the desired design performance is achieved meeting the applicable medical device FDA/European regulatory requirements and companies Policies & Procedures.
Salary
$120,450 - $176,660; Not specified; Comprehensive benefits package
Skills & Requirements
Must-have
ISO 14971 Risk Management
Design Verification and Validation
FDA Quality System Regulations
ISO 13485
Medical Device Directive
Root Cause Analysis
Nice-to-have
Collaboration and conflict resolution
Team leadership and coaching
Lean Sigma tools proficiency
Statistical methods expertise
Key Requirements
7-10 years of experience
Bachelor’s Degree in Engineering or related field
Master’s Degree preferred
Experience with FDA and European regulated medical devices