BD (Becton, Dickinson and Company) Quality Engineer I -(NPD & Post Market Surveillance) in Salt Lake City, Utah
Category: Medical Device/ R&D Quality
Job ID: 2018-11466
Career Level: experienced
Division: Salt Lake City, UT/ Vascular Access Devices - MDS
Location: Salt Lake City,Utah,United States
BARD has now joined BD is a global medical technology company that is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. We lead in patient and healthcare worker safety, and technologies that enable medical research and clinical laboratories. Our innovative solutions help advance medical research and genomics, enhance the diagnosis of infectious disease and cancer, improve medication management, promote infection prevention, equip surgical and interventional procedures, optimize respiratory care and support the management of diabetes.
Vascular Access Devices, a sub-business unit of Medication Delivery Solutions, focuses on developing, manufacturing, and distributing high-quality medical devices used by clinicians throughout the worldwide healthcare industry to access a patient’s vasculature. Our devices assist in the delivery of chemotherapy, blood products, antibiotics, and nutrition.
Summary of Position with General Responsibilities:
This position will be a mix of both new product development and post market surveillance as it relates to Quality.This position will be responsible for testing, test validations, protocols, risk analysis, statistical analysis, design, process and equipment in Quality.
Develop sampling plans by applying attribute, variable, and sequential sampling methods. Develop local procedures, Test Methods, and standards.
Develop and implement Statistical Process Control.
Leads investigations related to quality problems.
Ability to define and manage risk-management plan, risk assessment and risk-control tools.
Facilitate or independently lead non-conforming product investigations, including corrective/preventive actions and product remedial actions.
Responsible for systems assurance including documentation, testing and inspection, and product and process development.
Will support Manufacturing, New Product Development, and Regulatory (as applicable) to ensure systems are in compliance with internal and external guidelines and regulations.
Working knowledge of statistical analysis and software.
Identify and lead product and systems continuous improvement initiatives.
Communicate effectively at all levels within Quality, as well as cross-functionally with R&D, Regulatory Affairs, Manufacturing, Supply Chain, Customer Service, Marketing, and other functions as necessary.
Able to influence decisions in a cross-functional team setting.
Equipment Qualification Experience (IQ/OQ/PQ).
Execute design controls and analyzes design inputs.
May participate in internal/external audits.
Lead and support new product development execution of design control from concept through post-launch phases.
Support design change activities through product life-cycle.
Lead execution of ISO 14971 compliant Risk Management processes and tools (e.g. FMEA, FTA).
Essential job Functions:
The following duties and responsibilities are intended to be representative of the work performed by the incumbent(s) in this position and are not all-inclusive. The omission of a specific duty or responsibility will not preclude it from the position.
Ownership of projects with demonstrated technical competence.
Participates and/or leads cross-functional teams.
Works independently and is results-oriented.
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.
Provides technical support on components, material methods, systems, and equipment.
Develops physical and functional test requirements to assure specifications and regulations are met.
Writes, reviews, and approves protocols, reports, and data.
Conducts testing outlined in protocols and test methods.
Executes validation studies on equipment and processes, and conducts and/or participates in complaints investigations.
Understands and follows company procedures and regulatory requirements.
Participates in and provides input to training on department & division procedures, and policies.
Prepares and submits for approval requests for project funding. Participates in project planning, budgeting, scheduling and tracking.
Analyzes design, process, and test data.
Prepares and presents oral and written project updates and technical discussions.
Develops and implements procedures to provide easy to follow instructions.
A Bachelor degree in STEM (Science, Technology, Engineering, Math), and two (2) years of engineering experience OR
Master’s degree in STEM.
Preferred (Ideal candidate) :
Mechanical or Software Engineer
Risk Analysis & Statistical analysis experience
Test Method Validation experience
Medical Device Experience (including internships)
The incumbent must demonstrate the potential ability to perform the essential functions of the job as outlined in the duties and responsibilities.
Additional Desirable Qualifications Skills and Knowledge:
Ability to make and present engineering decisions
Strong interpersonal skills
Specific specialized engineering skills such as:
Basic engineering cost analysis,
Basic tooling 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 create and provide training.
Demonstrated comprehension of basic 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 work in cross-functional teams.
Understanding of regulatory 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