Senior R&D Engineer
$120,000–$130,000 year
On-site · Camarillo, California, United States
Job Summary
Senior R&D Engineer leads research, design, and development of bioprocessing components and complex assemblies from concept to commercialization. Drive innovation, prototyping, validation, and industrialization; manage cross-functional timelines, budgets, and resources; oversee design reviews, risk assessments (FMEA), regulatory and quality compliance (ISO 13485, GMP, ASME BPE); develop engineering standards and SOPs; collaborate with Scientists and Engineers to define specifications, and support CAPA, ECR/ECO activities; leverage CAD/3D printing and SUT expertise to improve manufacturability and cost-effectiveness; generate technical reports and documentation to support product delivery and lifecycle management.
Required Qualifications
- Bachelor’s degree in Mechanical, Electrical, Biomedical, or related Engineering field
- 7+ years of engineering experience within a biotechnology or pharmaceutical manufacturing facility
- 4+ years of Single-Use Technology (SUT) design experience (tubing, bags, filling needles)
- Experience designing molded plastic parts and assemblies for fluid handling
- Understanding of ISO 13485, ASME BPE or related standards
- Track record in product development from concept through commercialization
- Ability to manage multiple projects in a fast-paced environment
- CAD expertise (3D and 2D) and proficiency with Microsoft Office
- Experience with design controls, prototyping technologies (e.g., 3D printing), testing and validation methodologies
- Familiarity with GMP environments
- Strong communication and teamwork skills
- Ability to train and guide less experienced personnel
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