Job Description Summary
As the R&D Engineer III, your primary focus of this position will be 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; conduct process development activities to understand process inputs and outputs; 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 activities from R&D, Quality, Operations, and Regulatory Affairs.
Main Responsibilities Will Include
Design: Design components of a medical device, 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: assist in the development and optimisation of processes to understand key process inputs and outputs, using statistical 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. May lead or manage technicians or engineering interns.
Other Responsibilities May Include
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.
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 4 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; ability to assist in executing validation.
Excellent oral and written communication skills.
Ability to work in cross functional teams.
Ability to analyze data, interpret results, and write reports. Proficient in statistical software is a distinct advantage.
Knowledge of cGMP and GLP is a distinct advantage.
Training in Six Sigma or Design for Six Sigma is a distinct advantage.
Salary Range: €54,800.00 – €83,600.00 EUR Annual.
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.
#J-18808-Ljbffr