Process Development Associate Jobs in Gilbert, AZ

We are the people who give possibilities purpose

BD is one of the largest global medical technology companies in the world. Advancing the world of health is our Purpose, and it's no small feat. It takes the imagination and passion of all of us-from design and engineering to the manufacturing and marketing of our billions of MedTech products per year-to look at the impossible and find transformative solutions that turn dreams into possibilities.

This job description is intended as a summary of the primary responsibilities of and qualifications for this position. The job description is not intended as inclusive of all duties an individual in this position might be asked to perform or of all qualifications that may be required either now or in the future.

Primary focus of this position is to assist and lead R&D engineer medical device process development and testing. This would include developing, optimizing, and validating processes for building a medical device; building units for engineering; performing tests, and collecting and analyzing data.

Responsibilities:

• Product builds: Assist, coordinate, track and build product part or prototypes builds for engineering evaluation, validation, pre-clinical and clinical studies, marketing and commercial sales. Sets up and operates manufacturing equipment.

• Process Development: Assist in new process development for new or existing medical devices and processes, supporting tooling and equipment development. Assists in conceptual input to the design of fixtures, tooling and equipment, as well as assists with recommendation, specification and procurement of capital equipment.

• Documentation: Assist, prepare, develop, and implement documentation including work instructions, standard operating procedures, technical reports, change requests and formal test protocols and reports which comply with GMP and Quality requirements.

• Test Method Development: Review test methods during test method development and assists with test method validations.

• Testing: Ability to perform tests by following instructions from development engineers; collect data and record test results; analyzing test data, organizing, and presenting to peers and management when it is necessary in a reportable format. Assists in the execution of test protocols and procedures. Sets up test equipment for testing to protocols. Coordinates and manages testing of released protocols.

• Training: Provides process/test method training to manufacturing and QA personnel.

• Equipment: Perform and document equipment preventative maintenance and repairs on manufacturing equipment and systems per schedule. Ensure equipment is operating properly. Obtaining quotes for testing and calibration.

• Materials/Inventory: generate purchase orders, coordinate orders and deliveries with vendors, R&D stock checking including monitoring material and test inventory, shipping materials/receiving materials including to/from sterilization, ship testing and conditioning for R&D products, preparing commercial invoices and liaising with internal Customs specialists.

• Supervisory/mentoring/coaching: peer-peer coaching other technicians on R&D based tasks and responsibilities. Oversee activities of junior technicians in conjunction with their Engineering supervisor.

• Fiscal: reviews inventory reports, the transfer of R&D items to financial logs and relays information to R&D engineers/Project Leaders/R&D Managers for discussion with Finance.

• Ability to travel up to 10-25% of the time

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

Education and Experience:

• Minimum of a High school Diploma/GED. Associates of Science degree in science, math or engineering preferred.

• Experience: Minimum 5-8 years of industrial experience in R&D or process development, or Associates degree in science, math or engineering with 4 years related experience preferably in medical device or other regulated FDA/QSR and ISO environment.

Required Qualifications:

• Minimum of a High school Diploma/GED. Associates of Science degree in science, math or engineering preferred.

• Experience: Minimum 5-8 years of industrial experience in R&D or process development, or Associates degree in science, math or engineering with 4 years related experience preferably in medical device or other regulated FDA/QSR and ISO environment. Ability to work without supervision.

• Experience working in a laboratory and a controlled environment (cleanroom) with knowledge of GMP and GLP, and ability to operate lab equipment with practical and technical knowledge of common lab instrumentation and equipment used for test or pilot processes, is a plus.

Preferred Qualifications:

• Associates degree or higher in science, math or engineering preferred.

• Experience of electronic tools and equipment (soldering, multi-meter, oscilloscope and analyzer, etc.).

• Experience in process validation (IQ, OQ and PQ); ability to assist in executing validation.

• Proficiency in computer skills (MS Windows, MS Outlook, Word, Excel and PowerPoint) and ability to enter data in Microsoft Project and / or Minitab for data analysis.

• Ability to analyze and evaluate data and recommend actions; has practical and technical knowledge of root cause and statistical methods and analysis. Exposure to statistical analysis and experimental design helpful.

• Ability to design (fixture, equipment, and testing). Has general technical awareness of rapid prototyping techniques and an ability to read and understand CAD drawings (e.g. Solidworks).

• Interpret and understand geometric tolerances.

At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting.

For certain roles at BD, employment is contingent upon the Company's receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD's Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.

#earlycareer

To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of healthcare. At BD, you'll discover a culture in which you can learn, grow and thrive.

We believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture. Join us and enjoy a culture where face-to-face collaboration supports your learning, your progress, and your success.

To learn more about BD visit https://bd.com/careers.

Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to 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, and other legally protected characteristics.

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