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The R&D Engineer II performs design engineering functions in support of medical device product development programs across multiple therapeutic areas including cardiology, neurology, and urology. This role contributes to projects from concept through commercialization, ensuring deliverables meet customer requirements for quality, cost, and schedule performance.

The Engineer II works with moderate independence to execute engineering tasks, support project deliverables assigned by the Project Manager, and communicate technical status updates to cross-functional teams. Updates may include technical feasibility, schedule impact, budget considerations, and risk to project objectives.

This role also supports development of engineering processes, manufacturing readiness, and continuous improvement of product and design solutions within a regulated environment.

Key Responsibilities

Product Design & Development

• Follow the Aptyx Quality System, including all applicable SOPs and training requirements
• Develop and engineer medical devices from concept through production with little supervision
• Perform hands-on product assembly and process development for catheters and other medical devices
• Design devices, components, tooling, and fixtures using SolidWorks or equivalent CAD software
• Build prototypes and support laboratory-based development activities
• Engage with senior and principal engineers for technical guidance as needed

Manufacturing & Process Development

• Design and develop pilot and production tooling, fixtures, equipment, and manufacturing procedures with limited supervision
• Support installation, setup, and qualification of new equipment, including development of preventive maintenance (PM) procedures as needed
• Perform or support equipment maintenance and coordinate re-entry to production use, escalating issues to the Technology Manager when appropriate
• Assess process feasibility and support manufacturing with validation planning and time studies
• Develop manufacturing methods and support product transition into full production

Validation, Testing & Documentation

• Develop and execute verification and validation activities with limited supervision, including testing and documentation
• Prepare engineering documentation to support the quality system, including:
  • Test results and data analysis
  • Engineering drawings
  • Test reports
• Ensure compliance with good documentation practices and regulatory requirements
• Support engineering changes and updates to existing product lines as needed

Project Support & Communication

• Communicate directly with project teams and leadership regarding task status, risks, and technical challenges
• Support execution of project deliverables assigned by the Project Manager
• Provide input on technical feasibility, schedule, and budget impacts
• Demonstrate understanding of the design and development (D&D) process through execution of assigned work
• Support manufacturing and product development activities through commercialization

Vendor & Cross-Functional Collaboration

• Collaborate with external vendors on sourcing of materials, components, tooling, and manufacturing processes
• Support engineering teams in investigations related to customer complaints and product issues
• Work cross-functionally with Quality, Manufacturing, Supply Chain, and Project Management teams

Education

• Bachelor's or Master's degree in Biomedical Engineering, Mechanical Engineering, or related discipline required

Experience

• 3+ years of engineering experience in medical device development or regulated manufacturing environment
• Experience with catheter-based or complex medical device development strongly preferred

Skills & Qualifications

• Proficiency in SolidWorks or equivalent CAD software
• Strong experience in hands-on prototyping and mechanical assembly
• Knowledge of medical device materials and manufacturing processes (e.g., thermal bonding, PTFE processing, fixture design, etc.)
• Familiarity with validation (IQ/OQ/PQ), design controls, and regulated product development processes
• Strong analytical and problem-solving skills
• Excellent verbal and written communication skills
• Proficiency in Microsoft Office Suite
• Ability to use basic hand tools (drills, screwdrivers, wrenches, saws, etc.)
• Familiarity with multiple manufacturing methods used in device production

Physical Requirements

• Ability to work in both laboratory and manufacturing environments with variable conditions
• Frequent use of hands, arms, and fingers for engineering and technical tasks
• Ability to sit, stand, and move throughout production and lab environments
• Normal vision and hearing required for communication and technical work
• Must be able to effectively communicate in person, electronically, and via phone

Performance Expectations

• Adherence to the Aptyx Quality System and SOP compliance requirements
• Timely and accurate completion of engineering deliverables and documentation
• Clear and proactive communication of task status, risks, and technical issues
• Consistent on-time and on-budget execution of assigned work
• Proficiency in SolidWorks and adherence to internal drawing/documentation standards
• Demonstrated understanding of multiple medical device manufacturing technologies (e.g., bonding, fixture design, PTFE processing, etc.)
• Strong understanding of the design and development (D&D) process and its impact on project execution
• Demonstrated growth in technical capability, independence, and problem-solving ability