RD Engineer I, EU MDR

Company: CareFusion
Location: Tempe
Posted on: October 13, 2020

Job Description:

Job Description Summary Job Description This position must have a working knowledge of the design process and documentation for US, EU and OUS product launches. This position reviews the DHF for released products with regard to compliance to EU MDR, determine gaps, and develops mitigation plans and completes mitigation. This position is responsible for conducting engineering protocols and reports for product qualification and validations. This position should have working knowledge of New Product Development process, including design, development and implementation of new products, processes, test methods and equipment. This position is a temporary assignment which will include benefits such as (medical, health, dental, 401k). Eligibility for these benefits will be based on the eligibility requirements as determined by the BD Total Rewards policy, and is anticipated to last approximately through September 30, 2022. Job Description - This position must have a working knowledge of the design process and documentation for US, EU and OUS product launches. - This position reviews the DHFs for released productswith regard tocompliance to EU MDR, determine gaps, develops mitigation plans and completes the mitigation. - This position is responsible for conducting engineering protocols and reports for product qualification and validations. - This position should have working knowledge of New Product Development process, including design, development and implementation of new products, processes, test methods and equipment. - Initiates new or revised documentation and tracks through appropriate approval cycles and implementation. - Maintains a professional working relationship with internal and external customers and support staff. - Participates and/or leads cross-functional teams. - Provides technical support on components, material methods, systems and equipment. - Develops physical and functional test requirements to ensure specifications and regulations are met. - Writes and approves protocols, reports and data. - Oversees testing outlined in protocols and test methods. - Coordinates/develops validation studies on equipment and processes. - Conducts complaints investigations. - Understands and follows company procedures and regulatory requirements. - Participates in and provides input to training on department and division procedures, and policies. - Plans and coordinates engineering test builds. - Analyzes problems in design, process and test development. Recommends solutions. - Prepares and presents oral and written project updates and technical discussions. - Develops and implements procedures to provide easy-to-follow instructions. - Prepares and submits for approval requests for project funding. Participates in project planning, budgeting, scheduling and tracking. - Ability to travel within the US to design center(s) required. Qualifications - Bachelor's Degree required with at least 2-5 years (orMastersdegree with at leastone to three years) of engineering experience within the medical device or regulated industry. - Team leadershipexperienceandMasters Degreepreferred. - Experience with vascular access devices preferred,implanted central venous ports and catheters ispreferred. - Experience with enteral feeding product and drainage products is recommended. - Ability to make and present engineering decisions, along with strong interpersonal skills. - Specific specialized engineering skills such as: - Create and critique engineering cost analysis - Basic tooling and design and drafting knowledge - Analyze and optimize existing process and ability to create new processes - Create, analyze and optimize manufacturing and quality systems - Basic product, design & prototyping - Material science - Bioengineering principles - Ability to train, create and critique training - Comparative statistics - Software application skills - Problem solving ability - Ability to create, review and coordinate test protocols and reports - Ability to generate engineering proposals - Oral and written presentation skills - Ability to lead cross functional teams - Understanding of regulatory environment - Demonstrated ability to create and execute project plans - Demonstrated supervisory skills - Ability to create and control a budget. 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. EU MDR Primary Work LocationUSA AZ - Tempe Headquarters Additional LocationsUSA UT - Salt Lake City BPV Satellite Work Shift

Keywords: CareFusion, Tempe , RD Engineer I, EU MDR, Engineering , Tempe, Arizona