Sr. R&D Engineer

Responsibilities

• Lead new product development, product change, and design enhancement projects from concept through design transfer, ensuring scope, schedule, budget, and technical objectives are met.
• Own and execute design control activities, including user needs, design inputs, design outputs, design reviews, design traceability, and design history file (DHF) documentation.
• Translate customer, clinical, regulatory, and manufacturing requirements into clear product specifications and measurable acceptance criteria.
• Develop product concepts, CAD models, assemblies, drawings, specifications, and tolerance analyses for disposable medical device components and systems.
• Plan and execute design verification and validation strategies, including test method development, protocol development, sample size rationale, data analysis, and final reporting.
• Lead design FMEA, hazard analysis, risk analyses, risk control development, and risk management file updates in collaboration with Quality and Regulatory.
• Design and execute engineering studies, feasibility testing, design characterization, and design of experiments (DOE); analyze data using Excel, MINITAB, or other statistical tools.
• Lead cross‑functional project activities with Quality, Regulatory, Manufacturing, Supply Chain, Marketing, and external partners to ensure project deliverables are achieved.
• Drive root cause investigations and implement corrective design solutions for product performance, quality, reliability, or manufacturing issues.
• Research, evaluate, and specify materials, components, suppliers, and technologies based on functional requirements, biocompatibility, manufacturability, reliability, and cost.
• Coordinate with vendors to determine product specifications, evaluate samples, and ensure purchased components meet specifications and quality standards.
• Apply statistical methods, risk‑based approaches, and objective evidence to support product development decisions and design changes.
• Create and/or revise existing SOLIDWORKS CAD models, drawings, bills of materials, and product specifications in accordance with document control practices.
• Prepare and manage specifications, design documentation, test protocols, engineering reports, and other technical deliverables for new and existing products.
• Support design transfer to manufacturing by ensuring product requirements, inspection criteria, labeling inputs, and production support documentation are complete.
• Maintain a working knowledge of applicable government and industry quality assurance codes, standards, and medical device design control expectations.
• Mentor engineers and technical team members on NPD, design controls, risk management, technical documentation, and product development best practices.
• Complete special projects and assignments as requested by manager.

• Bachelor's degree in engineering or science with 7‑10 years of related experience, or equivalent combination of education and experience. At least seven years’ experience in medical device R&D, product development, design controls, or a regulated industry is required.
• Master’s degree preferred.
• Demonstrated experience leading NPD and product development projects from concept through design transfer, including design inputs, verification/validation, FMEA, risk analysis, and DHF documentation.
• Experience with SOLIDWORKS and MINITAB preferred.

• Excellent verbal and written communication skills; strong facilitation and interpersonal skills.
• Thorough experience and understanding of NPD, R&D, product development, design controls, design inputs/outputs, design reviews, traceability, FMEA, risk management, and verification/validation in a medical device setting.
• Experience with statistical software programs (e.g., MINITAB) and ability to apply statistical methods, design of experiments, sample‑size rationale, and data analysis.
• Knowledge of spreadsheet software, word processing software, CAD software, document control systems, and project management software.
• Provide SOLIDWORKS CAD support; experience in design for manufacturability, design transfer, supplier evaluation, and technical documentation…