Job Description Summary

Job Description

General Function

• Mentor and coach the BD-TCI team in technical aspects of projects in support of VAD.  Projects include, but are not limited to, supporting Advanced Access Devices 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.

Organizational Leadership

• Quality systems processes: Drive best practices in implementation of quality systems processes including design controls and change control.
• Technology transfer: Ensure efficient and effective transition from research to development to manufacturing in locations throughout the world
• Process effectiveness: Develop and implement appropriate processes for effective and accurate execution of 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).

Leadership

• 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
• Conducts cross-functional technical meetings to vet design trade-offs and proposed solution. Advocates, conducts and participates in Technical Reviews.
   
• Develops and maintains System Architecture documentation, including interface diagram, functional diagram etc.
   
• Execute Risk Management activities to ensure that design and process shortcomings are identified and appropriately addressed.
• Collaborate with a diverse technical team to create, update, and maintain documentation that is or will become part of the product design history file (DHF) for a PIVC products
• Work with subsystem teams, domain subject matter experts, and suppliers in the identification, logging, assessment, and resolution of integration and test issues.
• Provide technical leadership for product design, development, integration, testing, and reliability improvements.
•  Respond rapidly and flexibly to emerging issues in production, quality, engineering, or supply chain.
• Create and review process, design, and fixture documentation including work guidelines, specifications, and CAD models / drawings.

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.
• Minimum 8 years of experience in engineering/technical field, with 3 years demonstrated project and team leadership, preferably in the medical device industry with successful track record of project completion.

Required Skills

Optional Skills

.

Primary Work Location

Additional Locations

Work Shift