Lead Design Engineer

• Manage sustaining engineering projects and personnel including engineers and technicians. Projects include, but are not limited to, supporting Peripheral IV Catheter product lines, supply chain, and operations.
• Identify the best tools and approaches to effectively solve engineering problems to develop/optimize designs by leveraging appropriate mix of first principles / analytical, computational and experimental methods.
• Lead and ensure implementation and rigor of design control best practices with compliance to BD quality policies and procedures through appropriate communication, training, and education of sound quality assurance principals.
• Ensure compliance with all local, state, federal, and BD safety regulations, policies, and procedures.
  

• Quality systems processes: Ensure implementation of quality systems processes including design controls and change control.
• Project planning: Ensure quality and accuracy of integrated project plans encompassing all cross-functional activities and associated resource requirements.
• Project management: Ensure comprehensive and effective project plans are developed and actively monitor progress against plans. Be accountable for timely delivery of all project deliverables as specified in the plans.
• Budgeting: Develop detailed budgets in accordance with project plans. Manage budget diligently and be accountable to perform to the project budget.
• Stakeholder Management: Identify project stake holders, establish and monitor stakeholder engagement
• Technology transfer: Ensure efficient and effective transition from research to development to manufacturing in locations throughout the world
• Process effectiveness: Ensure appropriate processes are followed for effective and timely engagement of other parts of the company in project activities.
• Innovation: Develop and apply innovative approaches to ensure best outcomes in all aspects of the role. Support an environment in which innovation can flourish through empowerment, encouragement, and support.
  

Organizational Development:

• Proactively develop, maintain & share technical knowledge in specialized area(s), remaining up-to-date on current trends and best practices.
• Actively lead, mentor and motivate team members and junior associates, while also ensuring effective cross-functional communication and engagement
• Develop and apply innovative approaches to ensure the effective capture, retention and communication of technical and project knowledge generated (tacit & implicit).
  

• Responsible for leading, developing, and implementing critical component changes for high volume, disposable medical devices.
• Associate development: Actively develop and mentor associates. Provide frequent feedback. Continue to raise the bar on the group and help associates rise to expectations.
• Influence others: Intuitively and quickly assess people and situations and act accordingly. Demonstrate strong persuasion and timing skills. Remain open to be persuaded when appropriate.
• Inclusive work environment: Promote and leverage diversity to achieve best outcomes.
• Leadership courage: Demonstrate and promote leadership courage by doing what is right. Engage those who disagree to persuade or be persuaded. Instill confidence in associates and customers.
• Dealing with ambiguity: Demonstrate agility and action orientation when facing change and uncertainty. Effectively manage change and instill confidence.
• Analyze design solutions using engineering first principles and advanced engineering methods
• Write detailed technical reports based on design verification analysis/testing for design changes and product design activities
• Develop and execute test methods which specify measurement equipment, test set-up, measurement systems analysis, and data analysis
  

Qualifications

• Strong interpersonal and influence skills.
• Strong written and verbal communication skills.
• Advanced Problem-solving skills.
• Strong Cross functional Project Leadership skills.
• Strong technical and managerial judgment.
• Team orientation.
• Strong skills in project planning and management.
• Broad and deep understanding of disciplined change control processes, regulatory, and quality requirements.
• Strong motivational fit.
• Strong fit with BD values.
• Bachelor’s degree (or equivalent) in related technical field. Advanced degree preferred.
• 9-12 years of experience in engineering/technical field, preferably with 3 years demonstrated project and team leadership, preferably in the medical device industry with successful track record of project completion.
  

Required Skills