R&D Engineer Associate Level - Level II

Aptyx•Olympic Woods, NC

About The Position

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.

Requirements

Bachelor's or Master's degree in Biomedical Engineering, Mechanical Engineering, or related discipline required
3+ years of engineering experience in medical device development or regulated manufacturing environment
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
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
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

Nice To Haves

Experience with catheter-based or complex medical device development strongly preferred

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