Medical Device Product Development Engineer II

Acumed LLC; Hillsboro (OR); On-site; USD 90,000 - 120,000; Full time

Job summary

Acumed LLC located in Hillsboro, Oregon, leads medical device development from concept to commercialization. The Product Development Engineer 2 will work with cross-functional teams to design implants and instruments, using CAD and GD&T, while aligning with design controls and risk management processes.

The role emphasizes hands-on design, documentation, and collaboration with clinical experts, vendors, and customers to drive project delivery from concept through launch and sustaining transfers.

Qualifications

• Bachelor’s degree in Mechanical Engineering or Bio-Mechanical Engineering or equivalent with 2+ years’ experience preferred; or 8 years of medical device development experience.
• Clear communication with teammates and managers.
• Ability to lead PDTs on small projects.
• Experience writing test protocols and reports.
• 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 literature and patents; knowledge of design controls.
• Familiarity with anatomy and clinical indications.
• 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.

Skills

3D CAD modeling

GD&T knowledge

Design for manufacturability

Medical device development

ECO management

Root cause analysis

Literature review

IP landscape analysis

Cross-functional collaboration

Communication skills

Education

Bachelor’s degree in Mechanical Engineering or Bio-Mechanical Engineering

Tools

Windchill PLM

SAP

FEA basics

Job description

Acumed LLC located in Hillsboro, Oregon, leads medical device development from concept to commercialization. The Product Development Engineer 2 will work with cross-functional teams to design implants and instruments, using CAD and GD&T, while aligning with design controls and risk management processes.

The role emphasizes hands-on design, documentation, and collaboration with clinical experts, vendors, and customers to drive project delivery from concept through launch and sustaining transfers.