Development Engineering Tech I

We Are The People Who Give Possibilities PurposeBD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it's no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.Job DescriptionResponsibilities include but are not limited to:Lead in the identification and ensure implementation of opportunities to optimize/improve manufacturing processes including using engineering methods (e.g., SIX Sigma and LEAN methods) employing technical design skills to re-design/design of and ensure equipment, tools, fixtures, etc. are up to standardsDrive the development and execution of experiments and tests (including writing and executing protocols) on a simple product line to qualify and validate manufacturing processes; analyze results, make recommendations, and develop reportsCollaborate with first & second-tier suppliers on process development and process validation including IQ/OQ/PQ/TMVs.Establish project plans to ensure deliverables are completed to customer's expectations, using project management tools (e.g., Project Plan, Risk Analysis, etc.)CAPA, non-conformances, audit observations)Lead supplier related notification of changes (NOCs) including end of life (EOL) components and sub-assemblies to maintain fluid supply chain of finished products.Responsible for inspection method fixture development and implementation and qualification of inspection methods at contract manufacturer's receiving inspection & sub-tier suppliers' outgoing inspection.Develop training and documentation materials (e.g., work instructions) for production to enable the seamless knowledge transfer of project and manufacturing processesCollaborate with internal cross-functional teams, including Regulatory, Quality, Supply Chain, and R&D.Able to identify appropriate equipment, develop inspection methods, and fixtures to inspect or test Critical-to-Quality features. Perform appropriate Gauge Studies and statistical analysis to verify acceptability.Ability to read, interpret and modify 2D drawings & 3D CAD to ensure manufacturability and serve as a conduit between supplier and design teams.Demonstrate structured problem-solving approach for technical and logistical issues.Other incidental dutiesMinimum Knowledge, Skills, or Abilities (KSA's):Proven expertise in usage of MS Office Suite including MS Project; CAD experience preferred (if applicable)Strong documentation, communication (e.g., written and verbal) and interpersonal relationship skills including consultative and relationship management skillsBasic understanding of statistical techniquesPrevious experience working with lab/industrial equipment required (if applicable)Strong problem-solving, organizational, analytical and critical thinking skillsMinimal understanding of processes and equipment used in assigned workKnowledge of applicable FDA regulations for medical device industryStrict attention to detailAbility to interact professionally with all organizational levelsAbility to manage competing priorities in a fast-paced environmentMust be able to work in a team environment, including inter-departmental teams and key contact representing the organization on contracts or projectsAdhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/controlEducation and Experience:Bachelor's degree in engineering (preferred Biomedical, Mechanical, or Automotive) 3 years' experience including either industry or industry/education Required or;Master's Degree or equivalent in Engineering, 2 years' experience including either industry or industry/education preferred.We welcome people with the imagination and drive to help us reinvent the future of healthcare. At BD, you'll discover a culture in which you can learn, grow and thrive.To learn more about BD visit Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to 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, and other legally protected characteristics.Primary Work LocationUSA CA - Irvine Laguna CanyonAdditional LocationsWork ShiftAt BD, we reward, support and develop our associates through our comprehensive Total Rewards program. We are committed to attracting and retaining high quality talent by providing reward and recognition opportunities that promote a performance-based culture, as well as a competitive package of compensation and benefits programs. You can learn more on our career site under "Our Commitment to You."Our salary or hourly rate ranges reward associates fairly and competitively. The salary or hourly rate offered is determined by the role's specific requirements, including any applicable step rate pay system at the work location. Salary or hourly pay ranges are influenced by labor laws and Collective Bargaining Agreement (CBA) requirements applicable to the work location which may also affect the workplace arrangement of the role.