R&D Engineer III

Jobtailor; Arizona; On-site; USD 90,000 - 130,000; Full time

Job summary

Jobtailor in Arizona seeks an experienced mechanical/biomedical engineer to drive end-to-end product development for medical devices. You will lead cross-functional teams, develop specifications, manage validation activities, and coordinate testing across pre-clinical and clinical studies.

The role emphasizes data analysis, documentation, and collaboration with R&D to advance regulatory-compliant designs and supplier engagement. Clinical and regulatory awareness is required.

Qualifications

• B.S. degree in Mechanical, Biomedical, Chemical or related engineering.
• Minimum 6 years industrial experience in R&D or process development.
• Experience in process validation (IQ/OQ/PQ) and writing protocols/reports for verification and validation.
• Six Sigma or DFSS training.
• Master’s degree plus 1–3 years medical device or equivalent industry experience preferred.
• Experience in regulated FDA/QSR and ISO environments.
• Knowledge of cGMP and GLP.
• Experience creating and executing project plans.
• Experience leading cross-functional teams across time zones.
• Experience with project management tools.
• Basic tooling, design and drafting knowledge.
• Proficient in statistical software to analyze data and write reports.

Responsibilities

• Own end-to-end execution of product engineering projects including Sustaining Change Requests, Product Stewardship and Obsolescence projects.
• Extract, collect, analyze, and summarize data files and report to stakeholders.
• Design, develop and implement medical device products and processes, translating inputs into engineering specifications and drawings.
• Select materials, processes and vendors to achieve the design.
• Challenge designs against specifications, clinical use scenarios and international standards.
• Plan, coordinate and build test parts for evaluation, pre-clinical and clinical studies.
• Make and present engineering decisions.
• Lead cross-functional teams through design and development stages.
• Develop new or existing processes using key inputs/outputs and DOE as appropriate.
• Develop process equipment and tooling including specification development, vendor selection and negotiation.
• Prepare SOPs and work instructions, write technical documents and reports.
• Prepare raw material specifications and drawings.
• Prepare verification and validation protocols and reports.
• Develop or modify test methods and clinically relevant simulated use testing methods with R&D technicians.

Skills

Mechanical Engineering

Biomedical Engineering

Process Development

Design Specifications

Test Method Development

Technical Documentation

Material Selection

Engineering Drawings

Verification and Validation Protocols

Statistical Analysis

Education

B.S. degree in Mechanical Engineering

Master’s degree in relevant engineering discipline

Tools

CAD software

Job description

Responsibilities

• Own the end-to-end execution of product engineering projects, including Sustaining Change Requests, Product Stewardship requests, and Obsolescence projects.
• Extract, collect, analyze, and summarize data files and report to stakeholders.
• Design, develop and implement products and processes of a medical device, translating intangible design inputs into tangible engineering specifications and drawings.
• Select appropriate materials, processes and vendors to achieve the design.
• Challenge these designs against design specifications, clinical use scenarios and international standards.
• Plan, coordinate and build test parts for engineering evaluation, pre-clinical studies and clinical studies.
• Make and present engineering decisions.
• Participate and lead cross-functional teams through design and development stages.
• Develop new or existing processes by understanding key process inputs and outputs, using statistical methods such as DOE as appropriate.
• Develop process equipment and tooling, including specification development, vendor selection and negotiation.
• Prepare work instructions and standard operating procedures (SOP), write technical documents and reports.
• Prepare raw material specifications and drawings.
• Prepare verification and validation protocols and reports.
• Develop or modify test methods and clinically relevant simulated use test methods in conjunction with R&D technicians.

Requirements

• B.S. degree in Mechanical Engineering, Biomedical Engineering, Chemical Engineering or other related engineering discipline.
• Minimum of 6 years of industrial experience, preferably in R&D or process development.
• Experience in process validation (IQ, OQ and PQ), writing protocols and reports to support verification and validation activities for product commercialization; ability to execute validation.
• Training in Six Sigma or Design for Six Sigma.
• Master’s degree in relevant engineering discipline plus 1-3 years medical device or equivalent industry experience (preferred).
• Experience in R&D or process development in medical device or other regulated FDA/QSR and ISO environment.
• Knowledge of cGMP and GLP.
• Experience creating and executing project plans.
• Experience and willingness to lead cross functional teams, across multiple time zones (Domestic and International).
• Experience in project management tools and methodologies.
• Basic tooling, design and drafting knowledge.
• Proficient in statistical software with ability to analyze data, interpret results, and write reports.

ATS Optimization Keywords

Hard Skills

• Mechanical Engineering
• Biomedical Engineering
• Process Development
• Design Specifications
• Test Method Development
• Technical Documentation
• Material Selection
• Engineering Drawings
• Verification and Validation Protocols
• Statistical Analysis

Soft Skills

• Communication
• Collaboration
• Leadership
• Problem-Solving
• Presentation Skills

Certifications & Qualifications

• Six Sigma Certification