R&D Engineer III

R&D Engineer III executing product engineering projects in medical technology. Engage in design, validation, and cross-functional team collaboration to develop innovative healthcare solutions.

Posted 6/29/2026full-timeTempe • Arizona, New York • 🇺🇸 United StatesMid-LevelSenior💰 $95,900 - $153,400 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in product engineering for medical devices, including process validation, project management, and cross-functional team leadership. Proficient in statistical analysis and technical documentation to support product commercialization and compliance with regulatory standards.

Highest-signal resume keywords

Process Validation (IQ, OQ, PQ)Six Sigma TrainingProject Management ToolsStatistical Software ProficiencyCross-Functional Team Leadership

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Mechanical EngineeringBiomedical EngineeringProcess DevelopmentDesign SpecificationsTest Method DevelopmentTechnical DocumentationMaterial SelectionEngineering DrawingsVerification and Validation ProtocolsStatistical Analysis

Soft Skills

CommunicationCollaborationLeadershipProblem-SolvingPresentation Skills

Tools & Technologies

Project Management SoftwareStatistical Analysis SoftwareDesign SoftwareDrafting ToolsSOP Development Tools

Certifications & Qualifications

Six Sigma Certification

Industry Keywords

CGMPGLPFDAQSRISOR&DMedical DeviceProcess ValidationClinical StudiesObsolescence Management

About the role

Key responsibilities & impact

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

What you’ll need

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.

Benefits

Comp & perks

Health insurance
401(k) matching
Flexible work hours
Paid time off
Remote work options