Essential Responsibilities

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:

• 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.

Supervisory Responsibility

This position has no direct supervisory responsibility, but may provide technical guidance and mentorship to engineers and project team members.

Work Environment

This position operates in an office and manufacturing environment. This role routinely uses standard office equipment such as computers and phones. The position also interacts with machinery on the manufacturing floor and numerous devices that are sold by the company.

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.

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.

Required Education and Experience

• 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.
• 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.
• SOLIDWORKS and MINITAB experience preferred.

Position Requirements

• 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.
• Experience with statistical software program preferred (MINITAB, etc.); ability to apply statistical methods, design of experiments, sample size rationale, and data analysis.
• 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.
• 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/Security Clearance

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.

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.