BD Veterans

Job Information

BD (Becton, Dickinson and Company) Process Engineer in Baltimore, Maryland

Job Description SummaryThe Process Engineer is responsible for leading an R&D team in the design transfer of reagent and consumable manufacture processes to an Operations team. Working closely with representatives from R&D, Operations, Quality, Engineering and other functions, this individual will play an integral role in determining product specifications, optimizing component concentrations, determining consumable design and demonstrating robustness of performance using established quality policies and procedures. The individual will also provide oversight in the documentation of summary reports; manufacturing, quality control and standard operating procedures; and verification/validation protocols and reports associated with development of successful products. The candidate will be expected to work with a high degree of autonomy and apply expert knowledge to analyze, interpret and communicate work products to a range of technical and non-technical stakeholders. The ideal candidate will have strong leadership qualities, will establish a broad network and will be able to challenge ideas and successfully achieve goals while influencing at all levels within the organization. # Job Description ### Duties and Responsibilities: + ### Applies expert knowledge inscientific/engineeringtheories and innovative ideas to lead an R&D team in the execution of process development and design transfer across multiple product development efforts to meet business objectives. + ### Collaborates with representatives from R&D, Operations, Quality and Engineering to develop and execute on process development and design transfer plans that are aligned with product requirements, specifications, manufacture capability, quality policies/procedures and best practices. + ### Ensures that effective and efficient experimental designs and analyses are applied using appropriate tools and statistical robustness. Develops and/or adapts procedures to meet specific objectives and solve problems. + ### Interprets experimental results to determine appropriate course of action. Acts as a sounding board for testing scientific hypotheses and as a stimulus for the highest caliber of scientific rigor. + ### Formulates and conducts systematic investigation of problem areas of considerable scope and complexity which must be approached through a series of complex and conceptually related studies. + ### Develops policies/procedures to ensure effective achievement of scientific objectives. + ### Conceptualizes, prioritizes and schedules project deliverables. Determines trade-offs between product features, product cost & manufacturability, project schedule, and resource availability. + ### Drafts or directs the drafting of documents for Design Input, Design Verification, Design Validation, and Design Transfer. Ensures the documentation of executive summary reports that outline approach, results and conclusions associated with aspects of design development and optimization. + ### May serve as an R&D core team member on high impact program teams. + ### Provides input into the establishment and implementation of SOPs for manufacturing processes and manufacturing equipment. + ### Interfaces with other departments and internal/external partners to facilitate product development. + ### May be responsible for the maintenance of complex laboratory equipment and facilities. ### ### Knowledge and Skills: + ### Knowledge of, and experience in, process development associated with medical devices. Demonstrated ability to apply innovative approaches to diagnostic product development. + ### Knowledge of current state-of-the-art in nucleic acid extraction and amplification technologies as well as design and development of qualitative and quantitative real time PCR in-vitro diagnostic assays. + ### Demonstrated ability to learn new scientific and technological approaches. + ### Mastery of scientific method, experimental design, data analysis, and results interpretation. + ### Understanding of the theory of measurement, sources of error, and comparative advantages of different methodologies. + ### Demonstrated ability to work effectively within teams, across functions and with technical and business leaders. + ### Strong verbal, written, and interpersonal communication skills. + ### Capable of balancing multiple priorities and working under deadline pressure. Skills managing project teams in a matrixed organization and managing projects with multiple internal and external stakeholders and funders. + ### Working knowledge of the pertinent Quality Systems/Regulations (i.e. Quality System Regulation, ISO, FDA). ### ### Education and Experience: + ### PhD in scientific discipline (e.g. molecular biology, bioengineering, biochemistry, microbiology or virology) plus a minimum of 3 years’ experience in research and development and/or production leadership role specializing in the development and or manufacture of In Vitro Diagnostic products in a regulatory environment, or equivalent, is required. ### + ### B.S in scientific discipline (molecular biology, bioengineering, biochemistry, microbiology or virology) or equivalent plus a minimum of 8 years’ experience in research and development environment specializing in developing In Vitro Diagnostic products in a regulatory environment. + ### Knowledge and experience in reagent and consumables development and manufacture (e.g. plastics design and manufacture, reagent formulation and packaging) is required. + ### Application of complex experimental (e.g. DOE) and statistical methods to product optimization and problem solving is essential. + ### Experience in a regulated industry required, FDA preferred. + ### Minimum of 4 years of experience directly related to clinical molecular test development. Experience in diagnostic product development under design control is preferred. ### ### Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status. ### #LI-Pro # Primary Work LocationUSA MD - Sparks - 52/54 Loveton Circle # Additional Locations # Work ShiftNA (United States of America) Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

DirectEmployers