R&D Engineer Level II (Class II and III Interventional Device)

The R&D Engineer performs design engineering and technical leadership within the Development organization supporting the development of Class II and Class III medical devices across multiple therapeutic areas including cardiology neurology and urology.

This role supports or leads cross-functional project teams from concept through commercialization ensuring delivery of customer requirements for quality cost and timeline objectives. The engineer contributes to or leads technical execution communicates project status and ensures engineering deliverables align with regulatory and quality system requirements.

• Follow Aptyx Quality System including all applicable SOPs and training requirements
• Design and develop medical devices from concept through production with increasing independence based on level (Engineer II )
• Lead or support hands-on development of catheters and other medical devices including assembly and prototyping
• Design components devices tooling and fixtures using SolidWorks or equivalent CAD software
• Build prototypes and support laboratory development activities
• Develop and refine manufacturing methods processes and procedures through commercialization

• Develop pilot and production tooling fixtures equipment and assembly processes
• Support installation qualification and validation of new equipment
• Create and maintain preventive maintenance procedures as needed
• Perform or lead feasibility assessments process development and time studies
• Support manufacturing with troubleshooting process improvements and re-entry-to-line activities
• Escalate complex equipment or process issues to Technology Manager as appropriate

• Develop and/or lead verification and validation activities including test planning execution and reporting
• Prepare technical documentation to support design control requirements including:
  • Test protocols and reports
  • Engineering drawings
  • Design history file documentation
• Ensure compliance with good documentation practices and regulatory requirements
• Support design changes and product updates for existing product lines

• Communicate project status risks technical feasibility and resource needs to project teams and leadership
• Support or lead project schedules deliverables and technical execution depending on level
• Collaborate with cross-functional teams including Quality Manufacturing Supply Chain and Project Management
• Engage with senior engineers principal engineers and leadership for technical guidance and alignment
• Lead or support customer complaint investigations and corrective actions

• Collaborate with external vendors on materials components tooling and manufacturing processes
• Support or lead supplier technical discussions and development activities
• Assist in quotation and technical input for new product development opportunities (Senior level responsibility)

• Lead engineering deliverables and technical execution of projects
• Mentor and support development of junior engineers and team members
• Drive resolution of complex technical challenges with minimal supervision
• Support resource planning budgeting and technical input into project planning activities
• Contribute to continuous improvement of engineering practices and design standards

• BS or MS in Biomedical Engineering Mechanical Engineering or related discipline required

Engineer II:

• 3 years of experience in medical device engineering or related field

Senior Engineer:

• 6 years of experience in medical device engineering or related field

• Strong experience in medical device design and development
• Proficiency in SolidWorks or equivalent CAD software
• Hands-on prototyping and lab-based engineering experience
• Strong knowledge of materials and manufacturing processes (e.g. thermal bonding PTFE processing fixture design etc.)
• Experience with validation (IQ/OQ/PQ) and design controls
• Strong analytical and problem-solving skills
• Excellent verbal and written communication skills
• Proficiency in Microsoft Office Suite
• Familiarity with hand tools and manufacturing equipment

• Ability to work in both laboratory and manufacturing environments
• Regular use of hands arms and fingers for engineering and computer work
• Ability to sit stand and move within production and lab environments
• Normal vision and hearing required for documentation and communication
• Must be able to effectively communicate in person electronically and by phone

• Adherence to Aptyx Quality System and SOPs
• Timely and accurate completion of engineering documentation and deliverables
• Ability to clearly communicate project status risks and technical challenges
• Quality and completeness of design outputs and documentation
• On-time and on-budget execution of assigned project responsibilities
• Demonstrated proficiency in SolidWorks and engineering drawing standards
• Understanding and application of the design and development (D&D) process
• Demonstrated progression in technical depth autonomy and leadership based on level

Required Experience:

IC