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.
To learn more about BD visit https://jobs.bd.com/
Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
your information will be kept confidential according to EEO guidelines.
About the Company
BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. We have over 65,000 employees and a presence in virtually every country around the world to address some of the most challenging global health issues.
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