Senior Engineer I, Product Development

Senior R&D Engineer - BD

The Senior R&D Engineer will work cross functionally to lead research and development of complex medical devices, designing, developing and implementing new products and processes, and guiding teams through the complete product lifecycle.

Responsibilities

• Design, develop and implement new medical device products and processes, translating intangible design inputs into engineering specifications and drawings.
• Lead cross functional design teams and present engineering decisions.
• Generate intellectual property submissions.
• Develop new processes using statistical methods such as DOE, including specification development, vendor selection, and negotiation.
• Write and review product development plans, design reviews, technical documents and reports.
• Prepare and approve verification and validation protocols and reports; develop and implement procedures and policy.
• Develop engineering and clinically relevant test methods, and assist in their validation.
• Conduct engineering and competitor evaluations, and develop unit testing procedures.
• Plan, develop, execute and manage verification and validation activities for new products and processes.
• Train technicians and engineers on new design, process development and test methods.
• Mentor and coach R&D technicians and engineers through new product development activities.
• Create, control and manage a project budget and develop engineering cost analyses.

Qualifications

• B.S. degree in Mechanical Engineering, Biomedical Engineering, Chemical Engineering or a related discipline (Biomedical Engineering or Bioengineering preferred).
• 6+ years of industrial experience in R&D or process development, preferably in a medical device or regulated FDA/QSR and ISO environment.
• Hands on technical aptitude and experience in process validation (IQ, OQ, PQ) and writing protocols and reports to support verification and validation activities for product commercialization.
• Ability to create and execute project plans and lead cross functional teams.
• Basic knowledge of tooling, design and drafting.
• Excellent oral and written communication skills.
• Ability to analyse data, interpret results and produce reports.
• Proficient in statistical software.
• Training in Six Sigma or Design for Six Sigma.
• Knowledge of cGMP and GLP is a distinct advantage.

Compensation

€75,000-€78,000 annually.

Work 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, affectionate or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally protected characteristics.