BD (Becton, Dickinson and Company) Senior Engineer, Quality - MDR in Salt Lake City, Utah
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.
This position is responsible for system development and improvement along with managing projects with divisional impact 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.
Independently lead or facilitate 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.
Proficient in 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.
May supervise the efforts of a direct report.
Participate in collecting/developing and analyzing design inputs.
Equipment Qualification Experience (IQ/OQ/PQ).
Acts as a Division level Subject Matter Expert (SME).
Execute design controls and analyzes design inputs.
May support or lead internal/external audits.
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.
Consultant/Division expert; Division Technical expert.
Develops Innovative ideas for the organization.
Broad business and technical understanding.
Influences and directs others across organization; Coach/Mentor.
Critical Decision Maker in areas of engineering and business needs.Project Leader; Representative of BAS.
Initiates 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 and/or projects.
Provides technical support on components, material methods, systems, processes and/or equipment.
Develops physical and functional test requirements to assure specifications & regulations are met.
Writes and approves protocols, reports and data.
Manages testing outlined in protocols and test methods.
Manages/develops validation studies on equipment & processes.
Conducts and/or supports product complaint investigations.
Understands and follows company procedures and regulatory requirements.
Participates in and provides input to training on department & division procedures, and policies.
Manages project planning, budgeting, scheduling and tracking.
Analyzes problems in design, process, and/or test development. Recommend/implement solutions.
Prepares and presents oral and written project updates and technical discussions.
Develops and implements procedures/policy.
A Bachelor’s degree in STEM and six (6) years of engineering experience within a regulated industry, OR
Masters degree in STEM and four (4) years of engineering experience within a regulated industry.
Preferred Qualifications Include:
Experience in medical device industry strongly preferred.
Demonstrated knowledge of engineering principles through engineering experience including three (3) years of proven and effective project management skills.
The incumbent must demonstrate the potential ability to perform the essential functions of the job as outlined in the duties and responsibilities.
Ability to make and present engineering decisions.
Ability to systematically manage multiple projects from initiation through closing phases. Projects include BAS and/or supplier resourced deliverables:
Determine and communicate project deliverables.
Develop a work breakdown structure and estimates.
Develop a viable schedule, management plans, and schedule.
Execute and control the project through closure.
Specific specialized engineering skills such as:
Create & critique engineering cost analysis.
Basic tooling design and drafting knowledge, as applicable.
Analyze and optimize existing process and ability to create new processes.
Create, analyze and optimize relevant manufacturing and quality systems.
Ability to train, create and critique training; Problem solving ability.
Ability to apply comparative statistics, as required.
Software application skills.
Ability to create, review and coordinate test protocols and reports.
Ability to generate engineering proposals.
Oral and written presentation skills.
Comprehensive understanding of regulatory environment.
Demonstrated ability to create and execute project plans;
Advanced multi-project management skills.
Demonstrated Supervisory skills; Strong interpersonal skills.
Ability to create and control a budget.
Diverse technical background.
This position is in an office and laboratory environment and requires the incumbent to sit, stand and perform general office functions. The incumbent may also be required to lift up to twenty five pounds occasionally. The incumbent may be required to stand for extended periods of time. Bending, stooping and reaching are also frequently required.
The ideal candidate must be able to work in a team oriented, fast paced environment. Bard Access Systems is an affirmative action, equal opportunity employer that values and actively seeks diversity in the workforce.
Industry Standard/Category: Medical Device/ Quality
Career Level: experienced
Division Name: Salt Lake City, UT/ Vascular Access Devices - MDS
External Company Name: C.R. Bard, Inc.
External Company URL: www.crbard.com
Street: 605 North 5600 West
C. R. Bard, Inc. (NYSE: BCR) is a leading multinational developer, manufacturer and marketer of innovative, life-enhancing medical technologies in the fields of vascular, urology, oncology and surgical specialty products, employing over 13,000 people around the world. Founded in 1907, we pioneered many devices that are now the cornerstones of modern healthcare.
We expect the highest levels of quality, integrity, service, and innovation from our employees – on the job and in the communities in which we work and live. In return, we foster an environment where individuals are treated with fairness and respect, and feel valued, acknowledged and rewarded. Bard is a M/F, Disabled and Vet EEO/AA Employer.
Be Your Best at Bard – and ultimately, you can have an impact on the lives of people around the world.