Head of Mechanical Engineering

Overview

Oversee the entire mechanical product development lifecycle from concept through to mass production, ensuring high standards of quality and innovation.

Lead the design and prototyping of test fixtures and equipment for R&D and production, ensuring product reliability and manufacturability.

Technical Excellence

Create and review engineering drawings with a focus on GD&T best practices, ensuring compliance with standards and optimizing for manufacturing processes.

Perform engineering calculations (e.g., forces, stress, deflection, wear) and develop FEA models/simulations to validate designs.

3D CAD design for various manufacturing methods, including milling, turning, and injection molding.

Conduct and manage design reviews and releases in alignment with project schedules.

Team Management and Leadership

Lead and mentor a team of mechanical engineers, fostering technical growth and supporting project success.

Drive team performance by setting clear objectives, managing workloads, and providing regular feedback.

Cultivate a collaborative and innovative team culture, promoting continuous improvement and knowledge sharing.

Documentation and Compliance

Develop and manage product/project documentation throughout the product life cycle in line with the company’s ISO13485 Quality Management System (QMS).

Manage the creation and review of documentation such as Product Development Plans (PDP), Design Inputs/Outputs, and Verification & Validation Plans.

Oversee the creation and review of Failure Mode and Effects Analysis (FMEA), as well as Engineering Change Requests (ECRs).

Quality and Process Management

Analyze manufacturing data to ensure compliance with requirements and quality standards.

Plan and coordinate manufacturing process and material research and development activities.

Approve engineering documentation, drawings, and ECRs as required.

Qualifications

• 2-3 years of Senior Level Mechanical Engineering Experience; or related discipline
• 3-5 years of Engineering Leadership Experience
• 5+ years of relevant experience in medical device design/manufacturing or similar fields
• Bachelor’s degree in Mechanical Engineering or related fields
• Experience and skills in conflict resolution & team leadership.
• Lead engineer or manager for product(s) that made it to series production
• Proficiency in 3D CAD design, FEA, and 2D drafting/ drawings
• Experience with medical device design & manufacturing documentation throughout the product development process
• Experience with ISO 13485 or equivalent quality system requirements (e.g., regulated or compliance-driven environments)
• Self motivated and capable of driving and leading projects
• Good planning and time management skills
• Comfortable with and capable of solving very complex and ambiguous problems and managing multiple projects simultaneously

Nice to Have

• CAM & CNC experience

Location

This position is an in-office role at our Headquarters in Carrollton, TX

Salary & Benefits

$120,000 - $140,000 + Equity

Paid Time Off

401K & 401K Matching

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