SL
Senior Principal Engineer
Staftonic LLC
Indiana · On-site Full-time Lead 6d ago
About the role
About
We are seeking an experienced principal engineer to lead complex engineering initiatives within a regulated medical device manufacturing environment. This role involves solving system-level engineering problems, driving product and process improvements, and ensuring compliance with regulatory standards.
Key Responsibilities
- Lead investigations of product issues, complaints, and non-conformances
- Perform root cause analysis and support CAPA activities
- Support risk management and design control activities
- Lead process validation efforts (IQ/OQ/PQ) and production controls
- Collaborate with Quality, Regulatory, and Product Development teams
- Ensure compliance with ISO 13485 and FDA 21 CFR 820
Qualifications
- Bachelor’s degree in Mechanical, Biomedical, or related Engineering field
- 10+ years of experience in medical device or regulated manufacturing
- Strong knowledge of risk management, validation, and quality systems
- Excellent problem-solving and cross-functional collaboration skills
Requirements
- Strong knowledge of risk management, validation, and quality systems
- Excellent problem-solving and cross-functional collaboration skills
Responsibilities
- Lead investigations of product issues, complaints, and non-conformances
- Perform root cause analysis and support CAPA activities
- Support risk management and design control activities
- Lead process validation efforts (IQ/OQ/PQ) and production controls
- Collaborate with Quality, Regulatory, and Product Development teams
- Ensure compliance with ISO 13485 and FDA 21 CFR 820
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