Senior R&D Engineer

Senior R D Engineer SaniSure

LLC - 2.5

Camarillo, CA Job Details Full-time $120,000 - $130,000 a year 1 day ago Qualifications Product design project leadership Mechanical blueprint interpretation Experimental data reports Project development phase management New product introduction engineering projects 3D modeling software 3D printers Regulatory compliance Engineering project drawing management Employee relationship building Manufacturing facility Schedule management Bachelor's degree in engineering Records management Production validation processes Quality control documentation Pharmaceutical company experience Geometry 3D printing Prototype creation Bioprocessing Quality standards in production Research data analysis Design controls Biomedical regulatory compliance 2D CAD drafting Productivity software Research and development laboratory environment Training Design of individual components Full Job Description Job Summary The Senior 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. Essential Functions Stay current with emerging technologies, materials, and industry trends tomaintaincompetitive advantage. Drive innovation by exploringnew technologies, tools, and methodologies. Support intellectual property strategies byidentifyingpatentable technologies,workingwith legal team. Partner with cross-functional teams to ensure successful product development and launch, adhering toestablishedstage-gated process and governance model. Effectively project manage timelines, budgets, and resources to deliver high-quality results. Oversee the planning, design, development, prototyping, testing, and validation of new products and technologies. Conduct risk assessments usingFMEAframework, and drive risk mitigations as required. Lead design anddrawingreviews as needed. Ensure compliance with applicable regulatory, safety, and quality standards throughout the development process. Lead problem-solving, corrective, and preventative actions around product concerns originating both external and internal to the organization. Analysedata from validation tests todeterminewhether systems and processes meet required criteria and specifications. Maintain technical records within design history files. Drive continuous improvement in product performance,design formanufacturability(DFM), anddesign forcost-effectiveness(DTC). Develop and implement engineering best practices, design standards, and documentation protocols. Author SOP's, Work Instructions and Templates. Support Product Delivery Teams (PDT), including creating and or reviewing quality documents,participatingin CorrectiveAndPreventive Action (CAPA) implementation, and generating or supporting ECR (Engineering Change Request) & ECO (Engineering Change Order) activities. Workwith Scientists and Engineers internally and externally to assess and developappropriate designand manufacturing specifications. Perform other duties as assigned. Education Bachelor's degree in Mechanical, Electrical, Biomedical, or related Engineering field; Master's degree preferred. Required Experience & Competencies 7+ years of engineering experiencewithin 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. Demonstratedexpertisein the design ofmoldedplastic 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. Proventrack recordin product development, from concept through commercialization. Ability to manage multiple projects in a fast-paced, collaborative environment. Results-drivenmindset withkeen 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, prototypingtechnologies such as 3D printing, testing, and validation methodologies. Able to read andcomprehendand 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 andfacilitateassigned portions of product change management and control. Solidunderstanding of mathematical fundamentals of plane and solid geometry, fractions, percentages, ratios, and proportionsapplied topractical situations. Ability to interpret complex data sets,identifypatterns, and draw meaningful conclusions. Author scientific reports with conclusions and recommendations. Use data to drive decisions tied to the business context. Expert knowledge anddemonstratedhands-on experience with CAD software, both 3D and 2D. Proficient with Microsoft Office Suite or related software. Excellent verbal and written communication skills.

Strong interpersonal skills:

ability to interact with staff at all levels within the organization. Proactive approach toidentifyingopportunities for improvement and driving positive change. Develop andmaintainpositive rapport and working relationships with other personnel across the organization in support of initiatives to execute product improvements and enhancements. Experience working in a GMP (Good Manufacturing Practice) or laboratory environment.