R&D Engineer Level II-Senior

Aptyx•Charlotte, NC

About The Position

The Engineer II – Senior 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. Engineer II-level employees operate with moderate supervision, while Senior Engineers lead technical execution, mentor team members, and drive project outcomes with minimal oversight. Key Responsibilities Product Development & Engineering Execution 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 vs Senior) 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 Process Development & Manufacturing Support 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 Validation, Testing & Documentation 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 Project & Technical Leadership 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 Vendor & External Collaboration 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) Leadership (Senior Level Emphasis) 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 Education BS or MS in Biomedical Engineering, Mechanical Engineering, or related discipline required Experience 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 Skills & Qualifications 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 Physical Requirements 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 Performance Expectations 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

Requirements

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

Responsibilities

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 vs Senior)
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