Product Development Engineer 2 - Hand & Upper Extremity

Acumed-ffe1f67; Hillsboro (OR); On-site; USD 85,000 - 110,000; Full time

Job summary

Acumed LLC in Hillsboro, Oregon seeks a Product Development Engineer 2 to advance medical devices from concept to commercialization. You will develop implant and instrument designs, lead small PDTs, and communicate with cross-functional teams, clinicians, and customers.

The role emphasizes design control, risk management, testing, and documentation in a regulated environment, with CAD/FEA, GD&T, and PLM tools like Windchill and SAP; a degree in engineering and 2+ years of device experience

Qualifications

• Bachelor’s degree in Mechanical or Bio-Mechanical Eng; 2+ years in medical device dev preferred.
• Alternatively, 8 years of medical device development experience.
• Strong communication and cross-functional collaboration required.

Responsibilities

• Develop implant and instrument designs using CAD models, GD&T and clinical collaboration.
• Lead engineering deliverables for small projects from concept through launch.
• Support design control and risk management activities including traceability and verification/validation.
• Review CAD models for tolerancing and manufacturability; contribute to BKMs and QC checks.
• Support ECOs and engineering changes in PLM systems (Windchill, SAP).

Skills

Communication

Leadership

Problem solving

Documentation

Regulatory knowledge

Education

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

8 years medical device development experience

Tools

Windchill

SAP

Job description

Acumed LLCAs 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, OregonJob ScopeThe 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/ResponsibilitiesDevelop 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.QualificationsBachelor’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.