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. Required Education and Experience 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. Position Requirements 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 preferred. Competencies Problem Solving/Analysis Results Driven Detail Orientation Customer Focus Technical Capacity Communication Proficiency Additional Eligibility Qualifications None required for this position. Work Authorization Employees must be legally authorized to work in the United States. Employees must not be specifically barred from working with Federal contracts, government entities or otherwise listed on excluded parties lists as maintained by the Federal government. AAP/EEO Statement Erbe employees and applicants for employment are protected by federal laws, Presidential Executive Orders, and state and local laws designed to protect employees and job applicants from discrimination on the bases of race, religion, color, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, family medical history or genetic information, political affiliation, military service or other non‑merit‑based factors. These protections extend to all management practices and decisions, including recruitment and hiring practices, appraisal systems, promotions, and training and career development programs. Other Duties Please note this position description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. At‑Will Employment This position description does not constitute a contract or guarantee employment for any specified time. The company may exercise its employment‑at‑will rights at any time. Supervisory Responsibility This position has no direct supervisory responsibility, but may provide technical guidance and mentorship to engineers and project team members. Position Type and Expected Hours of Work This is a full‑time position. Days and hours of work are Monday through Friday, 8:00 a.m. to 5:00 p.m. Occasional evening and weekend work may be required, as job duties demand. Travel This position requires 10‑15% travel. Physical Demands The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing the duties of this job, the employee is regularly required to talk or hear. The employee frequently is required to stand, walk, and stoop; use hands to finger, handle or feel; and reach with hands and arms. The employee is occasionally required to lift and/or carry up to 20 pounds. For more information, please refer to the Position Analysis/Physical Activities Checklist on file in Human Resources. #J-18808-Ljbffr Erbe USA Incorporated