Senior Manufacturing Engineer

Job Description

General Purpose Summary:This is a high-level manufacturing engineering position for the third-party supplier and Tempe-related operations. This position is responsible for development of process improvements and validations of production processes.Requires a high-energy individual with excellent teamwork, partnering, and negotiation skills. Must demonstrate good judgment in selecting methods and techniques for obtaining solutions. High level and hands-on engineering position that leverages medical device development, quality and manufacturing experience. Responsible for the transfer of newly developed products to production.Essential Job FunctionsInitiates new or revised documentation and tracks through appropriate approval cycles and implementation.Maintains a professional working relationship with internal & external customer and support staff.Participates and leads cross-functional teams.Provides technical support on components, material methods, systems and equipment.Writes and approves protocols, reports and data.Manages testing outlined in protocols and test methods.Manages/develops validation studies on equipment & processes.Understands and follows company procedures and regulatory requirements.Participates in and provides input to training on department & division procedures, and policiesManages project planning, budgeting, scheduling and tracking.Plans and coordinates engineering test builds.Analyzes problems in design, process and test development. Recommend/implement solutions.Prepares and presents oral and written project updates and technical discussions.Develops and implements procedures/policy.Supervisor/Management Responsibilities:This role may supervise Manufacturing Support Engineering (MSE) associates.Fiscal/Budgetary Responsibilities:This role will participate in project planning, budgeting, scheduling and tracking.Customer and Key Contacts:Product development and various departments within BD PI.Outside suppliers.Basic Skills/Competencies Required:Excellent verbal and written communication skills.Highly motivated, self-starter with the ability to achieve results with minimal direction.Demonstrated proficiency in mechanical design, tolerance stack-up analysis, design for Manufacturability (DFM), and specification developmentDesign capability with small parts with an ability to read and understand mechanical drawingsWorking knowledge of PTFE and other materials typically used in medical devicesSignificant experience in product verification and validation testing, medical device new product development and rapid prototypingExperience in product verification via test equipment development and equipment validation (IQ/OQ/PQ) within an FDA regulated or other regulated industry (i.e. bio-tech/pharma, aerospace, food/beverage)Strong proficiency in technical writing of protocols and reportsProven capability in writing clear and detailed testing and product assembly proceduresImpeccable documentation skills and adherence to design control procedures and GLPDemonstrated experience in application of lean manufacturing principlesComfortable in a dynamic working environment with a high amount of changeDemonstrated ability in using statistical analysis techniques (i.e. Capability Analysis)Demonstrated ability with solid modeling (i.e. SolidWorks)Ability to make and present engineering decisionsStrong analytical and data skills (Excel VBA or other programming knowledge)Demonstrated ability to be self-taughtExperienced with CAD (SolidWorks) and mold simulation (Moldflow, ANSYS, etc.)Injection molding, plastic assembly and validation experienceEducation Required:Minimum Bachelor s degree in an engineering field, Master s preferredExperience Required:Prefer a minimum of 7 years experience in the medical field or closely related industry or a Masters Degree plus five years.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:Bard Peripheral Vascular is an affirmative action, equal opportunity employer that values and actively seeks diversity in the workforce.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.,

Keyskills :
kaizen leanmanufacturing safety inspection machining airquality newproductdevelopment verification validation ndo