Overview
R&D Engineer II role at BD. Primary focus is to support in developing, optimising, implementing, and validating components/elements of a medical device.
Responsibilities
* Design components, translating inputs into tangible engineering specifications and drawings. Select appropriate materials, processes and vendors to achieve the design, and challenge designs against 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. Support new process equipment and tooling development, including specification development, vendor selection and negotiation.
* Documentation: prepare work instructions and SOPs, 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
* 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 / Qualifications
* 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 is a distinct advantage.
* Training in Six Sigma or Design for Six Sigma is a distinct advantage.
Click on apply if this sounds like you!
At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving 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, while also recognizing flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting.
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.
To learn more about BD visit: https://bd.com/careers
Salary Range Information
€43,300.00 - €73,600.00 EUR Annual
Location: IRL Wexford - Enniscorthy; Enniscorthy, County Wexford, Ireland
Seniority level: Not Applicable
Employment type: Full-time
Job function / Industries: Biotechnology Research, Medical Equipment Manufacturing, and Research Services
Note: This description reflects the role content and does not include nonessential site-only notices beyond what is required for equal opportunity statements and basic compensation information.
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