Overview
Medical Murray is a privately owned medical device company founded in 1996, specializing in the development, testing, and manufacturing of finished devices, components, and subassemblies. As an R&D Engineer II, you will design and develop innovative medical devices while leading development projects from concept through production transfer.
Responsibilities
- Develop and engineer disposable medical devices from concept through commercialization.
- Design catheter-based delivery systems and other disposable medical devices using SolidWorks.
- Build, evaluate, and refine prototypes in a laboratory environment.
- Support product and process development activities for catheters and related disposable products.
- Lead design modifications and improvements to existing product lines.
- Lead development projects while managing timelines, technical deliverables, and project objectives.
- Communicate project status, risks, and technical updates to customers and internal stakeholders.
- Support project planning activities including schedules, resources, and budgets.
- Participate in project quotations and feasibility assessments.
- Drive projects forward through development phases while meeting customer expectations.
- Demonstrate leadership by sharing technical expertise and mentoring team members when appropriate.
- Develop feasibility, reliability, verification, and validation testing plans.
- Create and support in-vitro and in-vivo test methods and models.
- Manage and support verification and validation activities, documentation, and reporting.
- Assist with risk management activities including FMEA development and maintenance.
- Analyze test data and provide recommendations to support design decisions.
- Develop pilot and manufacturing equipment, processes, and procedures.
- Assess manufacturing feasibility and support process validations and time studies.
- Collaborate with Manufacturing Engineering to ensure successful technology transfer.
- Support manufacturing operations until projects are fully transitioned into production.
- Review manufacturing document changes for potential impact on design intent.
- Support acquisition, setup, installation, and qualification of new equipment.
- Create preventive maintenance procedures as required.
- Assist with equipment maintenance, troubleshooting, and escalation activities.
- Support equipment requalification and return-to-service activities.
- Collaborate with suppliers and vendors to source materials, components, and processing solutions.
- Follow all applicable Quality System requirements and Standard Operating Procedures.
- Prepare and maintain design control documentation including project plans, design inputs, design outputs, test protocols, reports, risk analyses, and drawings.
- Complete required project phase deliverables and documentation.
- Support customer complaint investigations and resolution activities.
- Ensure compliance with regulatory, customer, and internal quality requirements.