SR. PROCESS DEVELOPMENT ENGINEER I (Irvine CA)
BDAbout the role
Job Description Summary
Position Summary:This position actively participates as a key cross-functional team member on new product
development projects with a focus on design for manufacturability and the design, development,
implementation and validation of manufacturing processes, test methods and equipment
Job Description
We are the makers of possible
BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.
We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a maker of possible with us.
Key Job Responsibilities (including supervisory and/or fiscal):
Own the design, development, implementation, and validation of manufacturing processes for new products. This will include leading process development reviews, communicating process status and plans.
Lead project meetings and reviews with multi-functional team members to supervise project status and optimally follow up on action items
Connect with multi-functional team members and suppliers to understand and resolve product process and equipment specifications
May supervise and own the career development of technicians and/or engineers.
Document process development including manufacturing procedures, protocols, and reports
Develop and maintain a broad knowledge of product design, manufacture, and assembly techniques
Estimate resource requirements, workload assignment, production times for manufacturing processes
Train technicians, engineers, operations and quality assurance on new design and process development and test methods
Lead the manufacturing site selection process based on the evaluation of internal manufacturing sites, suppliers, and/or contract manufacturers
Participation in or creation and control of a project budget (expense and/or capital expenditure)
Participate as an authority and/or lead design and technology transfers to manufacturing
Required Qualifications:
Shown hands-on technical aptitude
Strong written, communication, and interpersonal skills
Ability to lead multi-functional teams
Ability to analyze data, interpret results, and write reports
Ability to build and implement project plan.
Basic tooling, design and drafting knowledge
Preferred Qualifications:
Experience with process validation (IQ, OQ, PQ)
Solid understanding of DOE and other statistical methods
Knowledge of cGMP and GLP
Training in LEAN, Six Sigma or Design for Six Sigma
Experience in design and technology transfers
PMO certification
Education and/or Experience:
Minimum B.S. degree in an engineering discipline
Minimum of 6 years of industrial experience in process development, preferably in medical device or other regulated FDA/QSR and ISO environment (Masters degree plus 4 years or Ph.D. degree with 3 years, medical device or equivalent industry experience).
Physical Demands:
While performing the duties of this job, the employee is regularly required to stand, walk, sit, use sight, and use hands to manipulate, handle or feel objects, tools, controls, and office equipment. The employee frequently is required to verbally connect with other associates. The employee is occasionally required to reach with hands and arms and stoop, kneel or crouch.
Work Environment:
While performing the duties of this job, the employee may be in an open cubicle environment. Candidate must be able to work in a team-oriented, fast-paced environment. BD is an affirmative action, equal opportunity employer that values and actively seeks diversity in the workforce.
For certain roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19. I
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