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R&D Engineer III
BDR&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
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
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
Mechanical EngineeringBiomedical EngineeringProcess DevelopmentDesign SpecificationsTest Method DevelopmentTechnical DocumentationMaterial SelectionEngineering DrawingsVerification and Validation ProtocolsStatistical Analysis
Soft Skills
CommunicationCollaborationLeadershipProblem-SolvingPresentation Skills
Certifications
Six Sigma Certification