Sr. R&D Engineer

Erbe USA Incorporated•Tempe, AZ

1d•Onsite

About The Position

The purpose of this position is to lead research, design, and development activities for new and existing medical devices manufactured in Tempe, Arizona. As a senior member of the Engineering team, responsibilities will include leading New Product Development (NPD) projects from concept through design transfer with emphasis on design controls, risk management, and cross-functional execution.

Requirements

Bachelor's degree from four-year College or University in engineering or science preferred with 7-10 years of related experience and/or training.
At least 7 years' experience in medical device R&D, product development, design controls, or other regulated industry.
Demonstrated experience leading NPD and product development projects from concept through design transfer, including design inputs, verification/validation, FMEA, risk analysis, and DHF documentation.
Excellent verbal and written communications required; strong facilitation and interpersonal skills required.
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.
To perform this job successfully, an individual should have knowledge of spreadsheet software, word processing software, CAD software, document control systems, and project management software.
Review drawings, key characteristics, tolerances, notes, specifications, requirements, and objective evidence.
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 list as maintained by the Federal government.

Nice To Haves

Master's Degree preferred.
SOLIDWORKS and MINITAB experience preferred.
Experience with statistical software program preferred (MINITAB, etc.); ability to apply statistical methods, design of experiments, sample size rationale, and data analysis.
Provide SOLIDWORKS CAD support; experience in design for manufacturability, design transfer, supplier evaluation, and technical documentation preferred.

Responsibilities

Lead new product development (NPD), 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.