Product Development Engineer 2

About the role

The Product Development Engineer 2 supports the development of medical devices from concept to commercialization, including research, planning, concept development, specification generation, testing, validation, and communication with cross-functional teams, management, and customers.

Responsibilities

• Develop implant and instrument designs using CAD models, drawings, and GD&T based on clinical research and collaboration with cross-functional teams and clinical experts.
• Lead engineering deliverables for small projects or portions of larger projects within Product Development Teams (PDTs) from concept through product launch and sustaining transfer.
• Communicate technical concepts effectively with internal teams, vendors, sales teams, and healthcare professionals.
• Support design control and risk management activities including traceability matrices, design verification and validation, design reviews, and associated testing.
• Evaluate designs through engineering analysis and testing including mechanical testing, cadaver labs, FEA, root cause analysis, tolerance stack analysis, and statistical tools.
• Review CAD models and drawings for tolerancing and manufacturability and contribute to Best Known Methods (BKMs) and quality checks.
• Support engineering change management activities including drawing approvals and Engineering Change Orders within PLM systems (e.g., Windchill, SAP).
• Research intellectual property landscapes and contribute to generation of new intellectual property.
• Develop expertise in assigned technical specialty areas and apply anatomical knowledge to product development projects.
• Support literature research, competitive analysis, and occasional customer-facing events.

Qualifications

• Bachelor’s degree in Mechanical Engineering, Bio-Mechanical Engineering, or equivalent with 2+ years’ experience preferred; or 8 years of medical device development experience.
• Ability to communicate clearly and effectively with teammates and managers.
• Ability to lead PDTs on small projects.
• Experience writing test protocols and reports and conducting testing with limited supervision.
• Applied knowledge of 3D/2D CAD modeling and drawings for implants or instruments.
• Knowledge of Level 1 & 2 GD&T principles.
• Basic FEA analysis knowledge to mitigate design risks.
• Experience managing ECOs through completion.
• Knowledge of root cause analysis techniques.
• Able to review medical literature, summarize clinical data, and write reports.
• Able to review patents and understand intellectual property considerations.
• Familiarity with design control processes in regulated environments.
• Understanding of anatomy and clinical indications for assigned projects.
• Able to conduct literature searches and develop competitive product analyses.