SR. PROCESS DEVELOPMENT ENGINEER I (Irvine CA)

$121,100 - $199,800/Yr

BD - Irvine, CA

Full-time - Mid Level

Irvine, CA

5,001-10,000 employees

Miscellaneous Manufacturing

About the position

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. At BD, one of the largest global medical technology companies, we are dedicated to advancing the world of health. Our purpose is to transform the impossible into possibilities through the collective imagination and passion of our teams, spanning design, engineering, manufacturing, and marketing of billions of MedTech products each year. We believe that the human element is crucial for our evolution, and we invite you to join us in an environment that supports your growth and development. In this role, you will own the design, development, implementation, and validation of manufacturing processes for new products. This includes leading process development reviews, communicating process status and plans, and leading project meetings with multi-functional team members to ensure optimal follow-up on action items. You will connect with team members and suppliers to resolve product process and equipment specifications, and may supervise the career development of technicians and/or engineers. Documentation of process development, including manufacturing procedures, protocols, and reports, is essential. You will also develop and maintain a broad knowledge of product design, manufacture, and assembly techniques, estimate resource requirements, and train team members on new design and process development and test methods. Additionally, you will lead the manufacturing site selection process and participate in the creation and control of project budgets. Your authority may extend to leading design and technology transfers to manufacturing, ensuring that all processes meet the required standards and specifications.

Responsibilities

• Own the design, development, implementation, and validation of manufacturing processes for new products.
• Lead process development reviews and communicate process status and plans.
• Lead project meetings and reviews with multi-functional team members to supervise project status and follow up on action items.
• Connect with multi-functional team members and suppliers to resolve product process and equipment specifications.
• 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, and 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 evaluations of internal manufacturing sites, suppliers, and/or contract manufacturers.
• Participate in or create and control a project budget (expense and/or capital expenditure).
• Participate as an authority and/or lead design and technology transfers to manufacturing.

Requirements

• 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).
• 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 plans.
• Basic tooling, design, and drafting knowledge.

Nice-to-haves

• 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.

Benefits

• Competitive salary range from $121,100.00 to $199,800.00 USD annually.
• Opportunities for professional development and learning.
• Performance-based rewards and recognition programs.