Job Description Summary # Job Description Position Summary: This position supports product leadership and risk management of new product development and sustaining. This position is part of the Quality Engineering Team whose responsibility is to support new product development and sustaining for combination drug products. Essential/Key Job Functions: • Technical leadership skills including an understanding of chemical and pharmaceutical operations (e.g., drug product manufacturing, process development, analytical, quality assurance). + The ability to create, support, review, and investigate analytical test methods used to support pharmaceutical combination devices. + The ability to create, support, review chemistry, manufacturing and controls device submissions • Participates as team leader or as an active member of the team to meet company objectives and ensure department responsibilities are completed. •Actively participates in training and providing input to training of employees on division procedures and policies. •Develop and implement procedures to comply with corporate and industry standards. •Coordinates and/or directs all aspects of product development activity related to a product line. •Leads development of risk assessments and test methods •Leads and/or support the Product Team on the device aspects of combination products •Leads product investigations •Ability to make and present risked based decisions •Assess product changes against product design •Quality engineering representation on Product Development Teams and Design Review Teams. •Prepare and present project updates and technical discussions. •Participate in project planning, budgeting, scheduling and tracking. •Support internal and external supplier audits. •Provide support to the regulatory department in writing technical submissions. •Complies with company procedures and policies, government regulations. Skills needed: •Knows how products are used and impact the user(s) so that risk can be managed effectively. •Apply Quality Engineering tools (Sampling Plans, Root Cause Analysis, Statistics, etc…) •Ability to develop solutions with business impact. •Advanced statistical and risk assessment techniques. •Working knowledge of test method (development and validation), equipment qualifications, process and design validation, risk assessment techniques, and component qualification methodologies. •Ability to make and present risk based decisions •Strong interpersonal skills •Ability to analyze and optimize manufacturing and quality systems •Ability to create and provide training •Problem solving ability •Ability to generate engineering proposals •Oral and written presentation skills •Ability to Lead cross functional teams •Understanding of regulatory requirements including 21 CFR 210, 211, ICH Guidelines, ISO 13485, ISO 14971 Required Qualifications: •Masters or Ph.D in Engineering, biological science, or a related engineer field. Fields of study include Chemical Engineering, Bioengineering, Pharmacy, or Biochemistry. •Minimum of eight years experience in engineering or Quality engineering experience within the medical device, pharmaceutical, or regulated industry. Preferred Qualifications: Quality Engineering Certification (ASQ) or equivalent. Physical Demands: While performing the duties of this job, the employee is regularly required to stand, walk, sit and use hands to manipulate, handle or feel objects, tools, controls and office equipment. The employee frequently is required to talk and hear. 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. 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. # Primary Work LocationUSA AZ - Tempe Headquarters # Additional Locations # Work Shift 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.