Senior Scientist - Design Control (Hybrid)
$117k - $184.2kMerck
Senior Scientist leading device design control activities for combination product development at Merck. Oversees regulatory compliance, cross-functional collaboration, and design control implementation throughout the product lifecycle in a hybrid New Jersey role.
Responsibilities
- Lead device design control activities and strategy for assigned combination product projects
- Prepare management presentations and regulatory submission materials
- Resolve project obstacles and coordinate cross-functional teams and external suppliers
- Ensure compliance with regulatory requirements and implement design control processes
- Contribute to development and enhancement of design control procedures and tools
Requirements
- Bachelor's degree in Engineering, Science, or related field plus 6 years experience
- 6+ years pharmaceutical, device development, or quality management experience
- Strong knowledge of regulatory requirements and medical device industry standards
- Analytical and statistical skills with risk assessment and data interpretation expertise
- Excellent communication, leadership, and problem-solving abilities
- ISO 13485, GD&T, mechanical design, and technical writing proficiency
Compensation: $117,000-$184,200 base
Vacancy posted 1 day ago
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