Product Development Engineer 2 - Hand & Upper Extremity

Marmon Holdings, Inc.•Hillsboro, OR

4d•Onsite

About The Position

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.

Requirements

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.
Ability to review medical literature, summarize clinical data, and write reports.
Ability 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.
Ability to conduct literature searches and develop competitive product analyses.

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.