R&D Engineer I - Product Engineering

Job Summary

R&D Engineer at BD to assist in developing, optimizing, and validating components and processes for medical devices in a regulated environment.

Responsibilities

• Design device components, translating design inputs into engineering specifications and drawings.
• Select materials, processes, and vendors, and evaluate designs against specifications, clinical scenarios, and international standards.
• Build test parts for engineering evaluation, pre clinical studies, and clinical studies.
• Assist in developing and optimizing processes, applying statistical methods such as DOE.
• Support new process equipment and tooling development, including specifications, vendor selection, and negotiation.
• Prepare work instructions, SOPs, technical documents, protocols, and reports.
• Develop engineering test methods and clinically relevant simulated use test methods.
• Conduct lab bench testing, engineering and competitor evaluations, unit testing, and verification/validation activities.
• Train technicians and operations staff on new designs, processes, and test methods.
• Mentor and coach R&D technicians through new product development activities.
• Assist manufacturing, quality, regulatory, and R&D in ensuring compliance with internal and external guidelines.
• Support design and process root cause analysis and non conforming product and complaint investigations.

Qualifications

• B.S. degree in Mechanical Engineering, Biomedical Engineering, Chemical Engineering or related field.
• Up to 2 years of industrial R&D or process development experience, preferably in a medical device or regulated FDA/QSR and ISO environment.
• Hands on technical capability with process validation (IQ, OQ, PQ) and writing of protocols, reports, and documentation.
• Excellent oral and written communication skills.
• Ability to collaborate within multi functional teams.
• Strong analytical skills: data analysis, interpretation of results, and report writing.
• Proficiency in statistical software is a plus.
• Knowledge of cGMP/GLP and experience in validation is advantageous.
• Training in Six Sigma or Design for Six Sigma is desirable.

Preferred Skills

• Experience in performance validation and cGMP/GLP environments.
• Six Sigma or Design for Six Sigma certification.

Compensation

Annual salary range: €44,800.00 - €68,350.00 (EUR). Bonus and benefits are included.

Location & Shift

Primary work location: Wexford - Enniscorthy. Work shift details to be discussed during interview.

Equal Employment Opportunity

BD is an Equal Opportunity/Affirmative Action Employer. The company does not unlawfully discriminate on the basis of 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, or any other protected status. BD evaluates applicants without regard to these characteristics and other legally protected categories.