Overview:
The Mechanical Engineer will contribute hands-on to the design, development, verification, and documentation of the Aurie Catheter System and adjacent products. This is a mid-level individual contributor role for an engineer with solid experience developing medical devices under formal design controls, owning CAD design work in SOLIDWORKS, managing product data within the 3DEXPERIENCE platform, and planning and executing verification & validation activities. The role reports into Aurie engineering leadership and collaborates closely with internal team members, external development partners, and contract manufacturers.
Role Commitment:
The role is a full-time position.
Details of the role commitment as follows:
- This is an onsite position based in Atlanta, GA.
- Occasional travel to development partner and contract manufacturer sites may be required to meet the needs of the business (estimated <10%).
Role Responsibilities:
Design & CAD Ownership
- Execute component design for manufacturing. Create subassemblies, assemblies and fixtures for the Aurie System from concept through design transfer, using SOLIDWORKS for 3D solid modeling. Create detailed drawings based on tolerance analysis.
- Propose, model, and implement design changes in response to test results, manufacturability feedback, and evolving user needs; support prototype design and assembly for feasibility studies.
- Contribute to prototype development, transition to manufacturing, and value engineering efforts to hit specific product cost targets.
- Apply GD&T, DFM/DFA principles, and material selection appropriate to disposable and durable medical device components.
Product Data & PLM Management (3DEXPERIENCE)
- Serve as a primary user and internal resource for the 3DEXPERIENCE platform, maintaining CAD data, part and document revisions, and released design outputs under configuration control.
- Create and maintain engineering bills of materials (BOMs), and process engineering change orders (ECOs) through review, approval, and release workflows.
- Maintain traceability between user needs, design inputs, design outputs, and verification results; keep Design History File (DHF) documentation current in the Aurie Quality Management System (QMS) as design and testing work is completed.
Verification, Validation & Testing
- Author test protocols and reports supporting design verification and validation, ensuring experiments are well-designed, documented, and statistically meaningful.
- Plan and execute bench testing, reliability studies, and service-life evaluations demonstrating that current and new designs meet requirements.
- Analyze test data, document results, and drive corrective design iterations; support root-cause investigations of test failures.
- Support process studies with contract manufacturing partners to establish process capabilities and baseline performance.
Quality & Cross-Functional Collaboration
- Perform all development work in accordance with Aurie design control procedures and the Aurie QMS, consistent with ISO 13485 and FDA 21 CFR 820.
- Contribute actively during internal and external engineering meetings, including brainstorming on how to efficiently address engineering challenges and accelerate validation of engineering approaches.
- Communicate effectively with suppliers, development partners, and team members across all operational levels of the organization.
- Remain current with industry standards and champion adoption of relevant standards and practices during all phases of development, including sustaining activities.
- Additional duties as assigned (will be explicitly defined in conversation with direct manager).
Qualifications
Required
- Bachelor’s degree in Mechanical Engineering or a closely related engineering discipline.
- Four to eight years of progressive mechanical engineering experience, with significant experience at medical device manufacturers developing products under formal design controls.
- Solid, demonstrated experience with SOLIDWORKS PLM solutions, specifically the 3DEXPERIENCE platform, including CAD data management, revision control, BOM management, and change management workflows.
- Proficiency in 3D solid modeling and detailed drawing creation in SOLIDWORKS, including GD&T per ASME Y14.5.
- Experience authoring and executing verification & validation protocols and reports within a regulated quality system (ISO 13485, FDA 21 CFR 820).
- Data-driven problem solving with excellent analytical skills; attention to detail and good organizational skills.
- Ability to self-manage: understanding organizational priorities, identifying overlaps between partner priorities and inputs, and driving key projects forward with limited managerial input.
- Ability to work effectively in a fast-paced environment with shifting priorities and multiple deadlines.
- Hands-on mentality with a desire to build things, learn new skills, and dive into work outside of one’s comfort zone.
Preferred
- Experience with catheter-based systems and electromechanical systems utilizing fluidics..
- Familiarity with FEA techniques and tolerance stack-up analysis.
- Understanding of basic analog and digital circuits. Ability to perform basic programming in Python
- Knowledge of Six Sigma practices, DFSS, DoE; statistical analysis tools (e.g., Minitab).
- Experience supporting design transfer to contract manufacturers.
- Experience administering or configuring 3DEXPERIENCE roles, workflows, or collaborative spaces.
- Experience with managing Master Models in CAD with surfacing.
Compensation & Benefits
- Salary range: $105-115k, commensurate with experience.
- Benefits: health/dental/vision insurance, unlimited PTO, 401k retirement plan with 3% employer contribution, equity stake.
Aurie is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
Pay: $105,052.96 - $115,000.00 per year
Application Question(s):
- NOTE: Preference will be given to those candidates who complete the pre-screening questions fully.
What is your proficiency level with SolidWorks and 3DEXPERIENCE PLM? Please list your level for each as beginner, intermediate, advanced, or no experience.
- Which manufacturing processes have you designed parts for? Please list the processes (ex: injection molding, machining, etc.) and briefly describe your experience.
- Which secondary or value-add processes (ultrasonic welding, die cutting, etc.) have you designed parts for? Please list the processes and briefly describe your experience.
Education:
Experience:
- Medical Device Design: 2 years (Preferred)
- 3DEXPERIENCE PLM: 2 years (Required)
- SolidWorks: 3 years (Required)
Location:
- Atlanta, GA 30318 (Preferred)
Work Location: In person
