Engineer II, DEV

Role Overview

• 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.

Requirements

• Bachelor's or master's degree in biomedical engineering, mechanical engineering, or related engineering discipline required
• 2–5 years of engineering experience within the medical device industry
• Experience with disposable medical device development preferred
• Experience with catheter-based products is highly desirable
• Experience leading technical projects and coordinating cross-functional activities
• Proficiency with SolidWorks or equivalent CAD software
• Strong knowledge of product design and development processes
• Experience with materials selection, prototyping, and manufacturing processes
• Understanding of design controls, verification, validation, and risk management principles
• Familiarity with medical device development and commercialization activities
• Experience supporting process development and manufacturing transfer activities.

Benefits

• medical (BCBS) and dental coverage
• company-paid vision and life insurance
• short
• and long-term disability
• HSA-eligible plans
• 401(k) Safe Harbor retirement plan
• 18 days of PTO
• TeleDoc access
• identity protection
• tuition reimbursement
• voluntary life insurance
• paid time off for community volunteering