The Research and Development Engineer leads research, design, and development of components and complex assemblies for critical bioprocessing applications. This individual will support innovation and product development through all stages, from ideation and concept, to prototyping, and through commercialization. Research and Development will result in deliverables and turnover packages that support swift industrialization.
Medical device, biotechnology, pharmaceutical, single use technology, injection molded plastic part design, iso 13485, cad experience, solidworks, autocad, gmp, bill of material, bom, fmea, engineering change orders, Engineering Change request, CAPA
Medical device, biotechnology, pharmaceutical, single use technology, injection molded plastic part design, iso 13485, cad experience, solidworks, autocad, gmp, bill of material, bom, fmea, engineering change orders, Engineering Change request, CAPA
• 7+ years of engineering experience within a biotechnology or pharmaceutical manufacturing facility.
• 4+ years of Single-Use Technology (SUT) design experience. Preferred experience includes design with tubing, bags, and filling needles.
• Demonstrated expertise in the design of molded plastic parts and assemblies for fluid handling of leak-proof applications.
• Thorough understanding of industry standards and regulatory guidelines. Knowledge of ISO 13485, ASME BPE, or related design standards.
• Proven track record in product development, from concept through commercialization.
• Ability to manage multiple projects in a fast-paced, collaborative environment. Results-driven mindset with keen sense of urgency and ability to deliver ahead of deadlines.
• Demonstrated attention to detail. Excellent follow-up skills.
• Must be self-motivated, amendable to a variety of work projects and work efficiently independently and as part of a team.
• Strong knowledge of design controls, prototyping technologies such as 3D printing, testing, and validation methodologies.
• Able to read and comprehend and interpret documents such as drawings, BOM's, blueprints, and operating procedures. Able to train and guide less experienced personnel on proper interpretation and best practices.
• Maintain organized and controlled records of all drawings and BOM's. Drive and facilitate assigned portions of product change management and control.
• Solid understanding of mathematical fundamentals of plane and solid geometry, fractions, percentages, ratios, and proportions applied to practical situations.
• Ability to interpret complex data sets, identify patterns, and draw meaningful conclusions. Author scientific reports with conclusions and recommendations. Use data to drive decisions tied to the business context.
• Expert knowledge and demonstrated hands-on experience with CAD software, both 3D and 2D.
• Proficient with Microsoft Office Suite or related
Intermediate Level
This is a Permanent position based out of Camarillo, CA.
The pay range for this position is $110000.00 - $120000.00/yr.
Internal company benefits provided
This is a fully onsite position in Camarillo,CA.
This position is anticipated to close on Jan 23, 2026.