Advanced Manufacturing Engineer I

Advanced Manufacturing Engineer I

The Advanced Manufacturing Engineer I (AMEI) will be primarily responsible for detailed project management, engineering support and direction for manufacturing activities to support the development and commercialization of new products.

In addition, this role may support sustaining engineering activities including capacity expansions and failure analysis on existing platform based products.

Support new product team design activities including:

• Provide concept development input
• Develop project plans and schedules
• Leading process reviews and assessing design for manufacturability

Plan, coordinate and manage all manufacturing activities associated with commercialization and launch of new products including:

• Concept and development of all methods and processes
• Coordination of all development and manufacturing of new tooling and equipment
• Coordination and support of all new vendor tooling
• Development and release of all product and process documentation including Process Specifications, Process Controls and PFMEAs
• Performing process characterization of all new operations and processes using design of experiments (DOE)
• Developing, executing, analyzing and writing reports for validation protocols
• Preparation of capital equipment requisitions

Plan, coordinate and manage all activities to transfer new products from design to manufacturing including:

• Development and management of a transition plan and team
• Process documentation transfer and review
• Facility selection, coordination & preparation
• Equipment moves and installation
• IQ, OQ, PQ protocol development and execution support
• Production startup and training support

Support sustaining manufacturing projects including:

• Leading / supporting failure investigations
• Project planning and execution of small to medium scale projects
• Protocol generation (characterization through validation) and execution
• Change implementation planning (including coordinating quality and regulatory timing with cross functional team)

Qualifications

Qualifications, Knowledge and Skills Required:

• BS degree in Engineering required (mechanical, chemical, biomedical or equivalent)
• AME I BS degree with minimum 3 years experience or MS degree with minimum 2 years experience
• Demonstrated proficiency in equipment and tooling procurement and chemical process design
• High level of written and verbal communication skills
• Ability to conceptualize ideas, motivate and focus individuals and teams and drive projects through completion on time and on budget
• Understanding and ability to execute DOEs, process validations and process characterizations
• Working Knowledge of Six Sigma methodologies. Six Sigma Green / Black belt certification preferred.
• Project management experience preferred
• Understanding of GMPs and medical device regulations as they apply to manufacturing
• Ability to travel up to 25%

Additional Information

For many roles at BD, employment is contingent upon the Company's receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, weekly testing for COVID-19 may be available instead of vaccination. Consistent with BD's Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.

Why join us?

A career at BD means being part of a team that values your opinions and contributions and that empowers you to bring your authentic self to work. Here our associates can fulfill their life's purpose through the work that they do every day.

You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. Our Total Rewards program which includes competitive pay, benefits, continuous learning, recognition, career growth, and life balance components is designed to support the varying needs of our diverse and global associates.