Product Development Engineer II - Upper Extremity (Medical Devices)

Location: Austin, Texas, USA; onsite work across office, manufacturing, mechanical testing lab, and cadaver lab environments

Company

hirify.global is an innovation-driven medical technology company developing clinically differentiated orthopedic solutions, including implants, surgical instruments, and digital health technologies.

What you will do

• Participate in new product development projects from proposal through final design and release for total shoulder arthroplasty instruments and implants.
• Translate surgeon requirements and product characteristics into concepts, mechanisms, CAD models, engineering drawings, prototypes, and released designs.
• Create and maintain design documentation, including risk assessments, design inputs and outputs, verification and validation plans and reports, test protocols, design reviews, and Design History Files.
• Define testing requirements, review designs for feasibility and technical soundness, and support FDA, ISO, and internal procedure compliance.
• Develop project schedules, budgets, specifications, cost estimates, and progress reports while collaborating with engineering, manufacturing, supply chain, quality, regulatory, marketing, customers, surgeons, and suppliers.
• Support prototypes, surgeon meetings, symposia, focus groups, cadaver labs, and quality or process improvements; lead engineering activities for approximately 20% of responsibilities.

Requirements

• Minimum 4 years of design and development experience; engineering co-op or internship experience is strongly desirable.
• Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, or an equivalent field.
• Ability to present information and answer questions from managers, clients, customers, regulatory agencies, sales representatives, and design surgeons.
• Ability to respond to customer, regulatory, sales, surgeon, and business-community inquiries or complaints.
• Ability to apply advanced mathematical concepts and statistical operations, including test reliability and validity analysis.
• Ability to define problems, collect data, establish facts, and draw valid conclusions.
• Ability to interpret extensive technical instructions in mathematical or diagram form and work with abstract and concrete variables.
• Knowledge of word-processing, spreadsheet, internet, and contact or change-management software.
• Travel required: less than 25%.

Nice to have

• Experience with 3D CAD packages, preferably SolidWorks or NX.
• Experience in medical devices or orthopedics.
• Experience working in a regulated industry.

Culture & Benefits

• Full-time employment in an innovation-focused medical technology environment.
• Work includes office, manufacturing, mechanical testing laboratory, and cadaver laboratory settings.
• Benefits include medical, dental, and vision insurance; spending and savings accounts; a 401(k) plan; vacation, sick leave, and holidays; income protection plans; discounted insurance rates; and legal services.
• hirify.global emphasizes collaboration, continuous improvement, scientific excellence, and improving patient outcomes.