Supplier Development Engineer II

We Are The People Who Give Possibilities Purpose

BD 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 Med Tech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.

Responsibilities 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 standards
• Drive 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 reports
• Collaborate with first & second-tier suppliers on process development and process validation including IQ/OQ/PQ/TMVs.
• Initiate and execute part qualification plan and reports.
• Establish project plans to ensure deliverables are completed to customer's expectations, using project management tools (e.g., Project Plan, Risk Analysis, etc.)
• Analyze and resolve Manufacturing and Compliance issues (e.g., 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 processes
• Collaborate 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 duties

Minimum 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 skills
• Basic understanding of statistical techniques
• Previous experience working with lab/industrial equipment required (if applicable)
• Strong problem-solving, organizational, analytical and critical thinking skills
• Minimal understanding of processes and equipment used in assigned work
• Knowledge of applicable FDA regulations for medical device industry
• Strict attention to detail
• Ability to interact professionally with all organizational levels
• Ability to manage competing priorities in a fast-paced environment
• Must be able to work in a team environment, including inter-departmental teams and key contact representing the organization on contracts or projects
• Adhere 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/control

Education 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…