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BD (Tissuemed Ltd) · 2 months ago

SR. PROCESS DEVELOPMENT ENGINEER I

Tempe, AZ

Contract

Onsite

Senior Level

6+ years exp

BD is one of the largest global medical technology companies in the world, dedicated to advancing the world of health. The SR. PROCESS DEVELOPMENT ENGINEER I will participate in new product development projects focusing on design for manufacturability and the validation of manufacturing processes and equipment.

Health CareHospitalMedicalMedical Device

Responsibilities

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

Qualification

Process developmentProcess validationProject managementStatistical methodsCGMPGLP knowledgeLEAN/Six Sigma trainingTechnical aptitudeData analysisDrafting knowledgeTraining skillsCommunication skillsInterpersonal skillsTeam leadership

Required

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

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)