R&D Engineer I
Job Description Summary
Be part of something bigger!
BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. We have over 65,000 employees and a presence in virtually every country around the world to address some of the most challenging global health issues.
The primary focus of this position is to collaborate with R&D, Quality, Operations, and Regulatory Affairs to support EU-MDR submission of products, including product gap assessments, planning and remediation of gaps within project timelines.
Successful candidates will assist in developing, optimizing, and validating components/elements of a medical device, assist/write technical documents, validation protocols and reports; prepare work instructions and standard operating procedures; assist in conducting design and process qualification and validation; support equipment development, support other associated activities. It is desirable for this position to have a working knowledge of new product development including design, development, and implementation of products, processes, test methods, and equipment.
Entry level engineer position to support testing for the EU MDR projects in Tempe, AZ.
Essential / Key Job Responsibilities (including supervisory and/or fiscal):
Participates in training related to EU-MDR gap assessment, planning and remediation.
Identifies and reviews supporting documents to meet EU-MDR requirements
Initiates new or revised documentation and tracks through appropriate approval cycles and implementation.
Provides a sound working knowledge of engineering principals, concepts, and practices.
Maintains a professional working relationship with internal and external customer and support staff.
Ability to work independently and as a member of a team.
Participates in and/or leads cross-functional teams.
Provides technical support on components, materials, test methods, systems, and equipment.
Develops physical and functional test requirements to ensure specifications and regulations are met.
Writes, reviews, approves, and executes protocols, reports, and data analysis.
Conducts testing or assists and oversees testing outlined in protocols and test methods.
Coordinates/develops and executes validation studies on product, equipment, and processes.
Conducts complaints investigations.
Understands and follows company procedures on regulatory requirements.
Participates in and provides input to training on department and division procedures, and policies.
Prepares and submits for approval requests for project funding. Participates in project planning, budgeting, scheduling, and tracking.
Maintains project plans and tracks project execution to timelines.
Plans and coordinates engineering test builds.
Analyzes problems in design, process and test development.
Prepares and presents oral and written project updates and technical discussions.
Develops and implements test procedures that provide easy to follow instructions.
Contribute to the Development and design of products and processes, performs tests, generates technical documents and analyzes problems.
Other Responsibilities may include, however are not limited to:
Assist in the support of Manufacturing, Quality, Regulatory & R&D to ensure systems are compliant with all internal and external guidelines.
Assist in design and process root cause analysis and support non-conforming product and complaint investigations.
Ability to travel within the US to design center(s) as required.
B.S. or M.S. degree in Mechanical Engineering, Biomedical Engineering, Chemical Engineering or other related engineering discipline. Biomedical Engineering or Bioengineering degree preferred.
Experience: 0-2 years of industrial experience in R&D or process development, preferably in medical device or other regulated FDA/QSR and ISO environment.
Demonstrated hands-on technical aptitude.
Experience in process validation (IQ, OQ and PQ), writing protocols and reports to support verification and validation activities for product commercialization.
Excellent oral and written communication skills.
Ability to work in cross functional teams.
Ability to make and present engineering decisions.
Comparative statistics and problem-solving ability
Ability to assist in executing validation is a plus.
Ability to analyze data, interpret results, and write reports. Proficient in statistic software is a plus.
Knowledge of cGMP and GLP is a plus.
Training in Six Sigma or Design for Six Sigma is a plus.
While performing the duties of this job, the employee is regularly required to stand, walk, sit, use sight, and use hands to manipulate, handle or feel objects, tools, controls, and office equipment.
The employee frequently is required to verbally communicate with other associates.
The employee is occasionally required to reach with hands and arms and stoop, kneel or crouch.
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.
Why join us?
A career at BD means being part of a team that values your opinions and contributions and that empowers you to bring your authentic self to work. Here our associates can fulfill their life’s purpose through the work that they do every day.
You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. Our Total Rewards program — which includes competitive pay, benefits, continuous learning, recognition, career growth, and life balance components — is designed to support the varying needs of our diverse and global associates.
To learn more about BD visit https://jobs.bd.com/
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.
Primary Work LocationUSA AZ - Tempe Headquarters
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Approbationdu Présiden et Chef de la direction
«Nous sommes une entreprise qui vise des résultats concrets et où nos associés s’emploient chaque jour à améliorer les soins de santé. De nombreuses initiatives sont en cours pour faire de BD un leader mondial des technologies médicales.»
Anonyme, Franklin Lakes, NJ