Product Development Engineer 2 - Hand & Upper Extremity

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 As a part of the global industrial organization Marmon Holdings—which is backed by Berkshire Hathaway—you’ll be doing things that matter, leading at every level, and winning a better way. We’re committed to making a positive impact on the world, providing you with diverse learning and working opportunities, and fostering a culture where everyone’s empowered to be their best. Location: Hillsboro, Oregon

Job Scope

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.

Duties/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. 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.

Following receipt of a conditional offer of employment, candidates will be required to complete additional job-related screening processes as permitted or required by applicable law.

We are an equal opportunity employer, and all applicants will be considered for employment without attention to their membership in any protected class. If you require any reasonable accommodation to complete your application or any part of the recruiting process, please email your request to [e-mail], and please be sure to include the title and the location of the position for which you are applying.

Welcome to the biggest small business you’ll ever find. Part of Berkshire Hathaway, Marmon is a global industrial organization made of 11 industry groups with 30K employees and $12 billion in annual revenue. As leaders in their respective industries, our 120+ companies thrive on an independent mindset and entrepreneurial spirit. At the same time, they benefit from being part of our industry groups—where they’re able to tap into the expertise and insights of other Marmon companies. While we’re all unique, we all share a common commitment to doing things that matter, leading at every level, and winning a better way. When you work at Marmon, you're advancing our everyday world and beyond. Our engineering solutions help millions around the world stay connected, healthy, and safe. Wherever you're at in your career, our people and resources will help you go further. As you grow your skills, you can also move up and around our 120+ companies. Work at a place you can stand behind. We show up to win every day, uphold the highest ethical standards, and always look to put each other in the best position to win.