Provide technical leadership for material and design changes to existing products (incl. packaging where appropriate) by following design control process.
Responsible for generating and/or updating all design-related protocols and reports related to the change.
Maintain the product Design Input Summary (DIS), Product Performance Specification (PPS), Design Trace Matrix (DTM), User/Design Failure Mode and Effects Analysis (U/DFMEA), Use-Related Risk Analysis (URRA) and other applicable design history documents.
Lead technical reviews for design changes.
Collaborate with Process Engineers, Quality Assurance, Supplier Quality, Planning, Purchasing, Regulatory, Manufacturing teams and other adjacent functions to maintain and improve products.
Plan and perform hands-on benchtop studies, troubleshooting and/or root-cause-analysis to evaluate product performance & improvements.
Lead or support activities for continuous process improvement and business continuity.
Support all stages of process validations (IQ, OQ, PQ, PPQ).
Support tender requests and evidence generation activities.
Requirements
BS degree in Engineering (specifically mechanical, chemical, biomedical or equivalent)
Eight (8) years of experience with a BS degree OR six (6) years of experience with an MS degree
Knowledge of design controls
Strong problem-solving and analytical skills
Ability to travel up to 30%
Minimum 4 days of in-office presence per week (for most roles at BD)
Benefits
Competitive salary
Rewards and recognition opportunities
Valuable, competitive package of compensation and benefits programs
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
design controldesign-related protocolsdesign history documentsroot-cause analysisprocess validationcontinuous process improvementtroubleshootingproduct performance evaluationrisk analysisfailure mode and effects analysis