R&D Engineer II

Overview

BD is a leading global medical technology company focused on advancing health through innovation in diagnostics and patient care. This role supports the development and improvement of medical devices by managing design changes, validating processes, and leading cross functional teams.

Responsibilities

• Design, develop, and implement changes to existing medical device products and processes, translating design inputs into engineering specifications and drawings.
• Lead and participate in cross functional teams for design changes and generate intellectual property submissions.
• Support sustaining activities for current medical devices.
• Develop or modify processes using statistical methods such as DOE, and design/discuss process equipment and tooling, including vendor selection and negotiation.
• Write and review change control plans, design reviews, technical documents, and reports.
• Prepare verification and validation protocols and reports; develop new engineering test methods and simulated use test methods with R&D technicians.
• Conduct engineering and competitor evaluations and development unit testing.
• Execute and manage verification and validation activities for product and process changes.
• Train technicians and engineering interns on new designs, processes, and test methods.
• Mentor or coach R&D technicians and engineering interns throughout New Product Development and/or Change Control processes.
• Support Manufacturing, Quality, Regulatory, and R&D to ensure compliance with internal and external guidelines.
• Perform root cause analysis and support investigations of non conforming products and complaints.

Qualifications

• B.S. degree in Mechanical, Biomedical, Chemical Engineering, or related discipline.
• 1-3 years of industrial experience in R&D or process development within a regulated FDA/QSR and ISO environment.
• Proficiency in industrial process validation (IQ, OQ, PQ) and writing protocols and validation reports.
• Hands on technical aptitude and proficiency with statistical software.
• Excellent oral and written communication skills and ability to work in cross functional teams.
• Strong analytical skills with ability to interpret data and write reports.
• Knowledge of cGMP, GLP, Six Sigma, or Design for Six Sigma is a plus.

Salary

€54,000-€57,000 per year.

EEO Statement

BD is an Equal Opportunity Employer. We do not 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, gender identity, sexual orientation, genetics, disability, military eligibility, veteran status, or any other protected characteristic.