R&D Engineer II, Product Development

Job Description

As the R&D EngineerII, you will support in developing, optimising, implementing, and validating components and elements of a medical device. You will perform hands on testing for optimisation, conduct process development activities to understand process inputs and outputs, and assist/write technical documents, validation protocols and reports. You will prepare work instructions and standard operating procedures, support equipment development, and collaborate with R&D, Quality, Operations, and Regulatory Affairs to ensure compliance.

Responsibilities

• Design: Design components of a medical device, translating intangible design inputs into tangible engineering specifications and drawings; select appropriate materials, processes and vendors; challenge designs against specifications, clinical use scenarios and international standards; build test parts for engineering evaluation, pre clinical and clinical studies.
• Process Development: Assist in the development and optimisation of processes to understand key inputs and outputs, using statistical methods such as DOE; support new process equipment and tooling development, including specification, vendor selection and negotiation.
• Documentation: Prepare work instructions and standard operating procedures (SOP); write technical documents, 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 with R&D technicians; prepare and assist in validating the test methods.
• Testing: Perform lab bench testing, engineering and competitor evaluations, development unit testing, and execute verification and validation activities.
• Training: Train technicians on new design, process development and test methods; assist or conduct new process development training with operations and quality assurance.
• Supervisory / mentoring / coaching: Mentor and coach R&D technicians through new product development activities such as process development, materials/inventory control; may lead or manage technicians or engineering interns.
• Other Responsibilities: Assist Manufacturing, Quality, Regulatory and R&D to ensure systems are compliant with internal and external guidelines; support design and process root cause analysis and investigate non conforming products and complaints.

Qualifications

• B.S. degree in Mechanical Engineering, Biomedical Engineering, Chemical Engineering or related engineering discipline; Biomedical Engineering or Bioengineering degree preferred.
• Up to 3 years of industrial experience in R&D or process development, preferably in a medical device or regulated FDA/QSR and ISO environment.
• Demonstrated hands on technical aptitude; experience in process validation (IQ, OQ and PQ) and writing protocols and reports to support product commercialisation.
• Excellent oral and written communication skills; ability to work in cross functional teams; analyze data, interpret results and produce reports.

Preferred Skillset

• Proficient in statistical software.
• Knowledge of cGMP and GLP.
• Training in Six Sigma or Design for Six Sigma.

Salary

€46,000 - €48,000 annually.

Location

IRL Wexford - Enniscorthy.

Equal Opportunity Employer

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.