Join to apply for the R&D Engineer II role at BD Nogales Norte
As the R&D Engineer II, your primary focus is to support in developing, optimising, implementing, and validating components/elements of a medical device.
You will perform hands‑on testing in optimisation of a device and conduct process development activities to understand process inputs and outputs. Assist and write with technical documents, validation protocols and reports. Prepare work instructions and standard operating procedures and assist in conducting design and process qualification and validation, support equipment development, support other activities from R&D, Quality, Operations, and Regulatory Affairs.
Main Responsibilities Will Include
* Design: Design components, translating intangible design inputs into tangible engineering specifications and drawings. Select appropriate materials, processes and vendors to achieve the design, and challenge these designs against design specifications, clinical use scenarios and international standards. Build test parts for engineering evaluation, pre‑clinical studies and clinical studies.
* Process Development: Assists in the development and optimisation of processes to understand key process inputs and outputs, using statistic methods such as DOE as appropriate. Supports new process equipment and tooling development, including specification development, vendor selection and negotiation.
* Documentation: Prepare work instructions and standard operating procedures (SOP), write technical documents and reports. Prepare raw material specifications and drawings. Assist in preparing verification and validation protocols and reports.
* Test Method Development: Develop new engineering test methods and clinically relevant simulated use test methods in conjunction with R&D technicians; prepare and assist in the validation of test methods.
* Testing: Perform lab bench testing, conduct engineering and competitor evaluations, development unit testing, and execute verification and validation activities.
* Training: Train technicians on new design and process development as well as new test methods. Assist/conduct new process development training with operations and quality assurance.
* Supervisory/mentoring/coaching: Mentor/coach R&D technicians through New Product Development activities like new process development, R&D materials/inventory control etc.
Other Responsibilities May Include
* Assist in the support of Manufacturing, Quality, Regulatory and 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.
About You
* B.S. degree in Mechanical Engineering, Biomedical Engineering, Chemical Engineering or other related engineering discipline. Biomedical Engineering or Bioengineering degree preferred.
* Up to 3 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 commercialisation, ability to assist in executing validation.
* Excellent oral and written communication skills.
* Ability to work in cross functional teams.
* Ability to analyse data, interpret results, and write reports.
* Proficient in statistic software is a distinct advantage.
* Knowledge of cGMP and GLP a distinct advantage.
* Training in Six Sigma or Design for Six Sigma a distinct advantage.
Click to apply if this sounds like you!
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 recognising the importance of flexibility and work‑life balance.
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, affections or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally‑protected characteristics.
Salary Range: €43,300.00 – €73,600.00 EUR Annual
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