Provide design control and risk management oversight to various development projects. Serve as back up Risk Manager where required.
Facilitate risk assessments for new designs and design changes at various project development phases. Ensure that risk management activities are performed in accordance with company procedure
Ensure compliance with applicable regulatory agency requirements, published standards, company policies/procedures, local procedures/work instructions, and project specific plans. This includes evaluating gaps for IVDR, generating plans for addressing the gaps and ensuring successful implementation of standards/procedures to support IVDR compliance
Provide guidance to project teams on project specific processes and deliverables. Ensure key elements of product developments are documented in design and development plan or design change plan. Ensure Plans are established and updated timely
Generate and analyze customer feedback data to improve product reliability and performance for our customers that is within the scope of the project
Support development of concise and complete verification and validation strategies that efficiently generate bodies of objective evidence to confirm product requirements compliance and the global regulatory submission strategy. Ensure all test anomalies/deviations are investigated, cause determined, impact assessed, plan of action defined, and resolution is verified
Ensure the product Design History File (DHF) is auditable, traceable, concisely organized, complete, and supports regulatory product registration needs
Drive continuous improvement of new product development procedures, methods, tools, techniques, and training, etc. to support project specific efficiencies.
At Danaher, we are dedicated to building and sustaining a truly diverse and inclusive culture. These are not just words on a page
Diversity and Inclusion is a top priority for the company, and it ties deeply to each of our core values. Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law.
BS in Biochemistry, Immunology or related technical field with minimum of 9 years of experience or Master's degree in field with minimum of 7 years of experience, or Doctoral degree with 4 years of experience
Demonstrated skills in design control processes, including design change, risk management, design requirements, design V&V, and design transfer.
Fluent in English language
Proficient in word processing, spreadsheets, MS PowerPoint, and project management skills
Well-developed written and oral skills
Minimum 2 years of experience in QA, design assurance or demonstrated skills in the new product development process preferred
Strong technical background in areas of reagent development or similar related function
Knowledge in instrumentation including system integration (hardware, software, reagents)
Ability to perform detail-oriented work with a high degree of accuracy;
Working knowledge of US and International regulations and standards (QSR, ISO, CE-IVD, GLP, cGMP, CLIA, Japan GMP, CMDR)
Experience in Verification and Validation & Product Submission/Registration
Experience in transferring new products from design to production;
Effectively communication skills to ensure positive outcomes across a multidisciplinary team
Strong technical writing skills
Risk Specialist, with full understanding of risk management regulations (ISO 14971), and principles and practices
Skilled in the use of risk management tools such as PLRAs, SRAs, and Risk Management Plans and Reports
Working knowledge of statistical techniques and quality/reliability tools (FMEA, FTA, DOE, SPC, etc)
Proficient in data analysis with experience using issue analysis/problem solving tools (root cause analysis, PSP, etc)
Ability to support several projects simultaneously while effectively adapting to changing project parameters
Stand/Sit/Walk 8 hours/day; ability to travel across campus and between facilities
Able to use computer & monitor to develop, review and communicate job-related documentation
Correctable to 20/20 in 1 eye and 20/40 in other eye. Able to use computer & monitor to develop, review and communicate job-related documentation.
Hearing requirements: Able to participate in meetings and conference calls and to use a telephone.
Minimal travel as needed, < />