Principal Engineer
$112k - $154kBaxter Healthcare
Principal Engineer role at Baxter focused on product and process development for IV solutions and delivery systems. The position requires leading cross-functional initiatives in materials assessment, packaging solutions, and regulatory compliance within a medical device manufacturing environment.
Responsibilities
- Lead product and process development initiatives for IV solutions and delivery systems
- Perform risk assessments related to materials, manufacturing processes, and patient safety
- Evaluate and implement non-DEHP materials and alternative packaging solutions
- Oversee validation, stability, compatibility, and extractables/leachables studies
- Support regulatory submissions, audits, and global compliance requirements
Requirements
- Bachelor's degree in Engineering with 7+ years of regulated industry experience
- Cross-functional project leadership in product development, manufacturing, and quality
- Risk management, validation, design controls, and change management expertise
- Materials, packaging, and container-closure systems knowledge
- FDA, GMP, ISO, and global regulatory requirements familiarity
- Technical investigation and CAPA implementation capability
Compensation: $112,000-$154,000 base
Vacancy posted 1 day ago
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