The posting
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 [email protected], and please be sure to include the title and the location of the position for which you are applying.
