3 дня назад
Principal Research & Development Engineer (Medical Devices)
131 200 - 196 800$
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Описание вакансии
Текст:
TL;DR
Principal Research & Development Engineer (Medical Devices): Developing spinal implant and instrumentation systems from concept through commercialization with an accent on mechanical design, systems engineering, and regulated medical-device development. Focus on translating surgeon and customer needs into product requirements, executing verification and validation, and mitigating technical risks through testing and analysis.
Location: Remote within the United States; based within the Spine Hub in San Diego, California. Domestic travel of approximately 1–2 days per month is expected for customer engagements, testing, cadaver labs, and project needs.
Salary: $131,200–$196,800 USD annually, excluding Puerto Rico and certain California locations.
Company
develops healthcare technologies, including spinal implants, instrumentation, navigation, biologics, and related surgical solutions.
What you will do
- Lead the design and development of spinal implant and instrumentation systems from concept through market release.
- Translate customer and surgeon insights into stakeholder requirements, system requirements, design specifications, and engineering concepts.
- Develop mechanical designs using 3D CAD tools and apply engineering drawing and geometric dimensioning and tolerancing standards.
- Assess and mitigate technical risks through design reviews, testing, analysis, and structured development activities.
- Plan and execute verification, validation, bench testing, and experimental evaluations.
- Collaborate with cross-functional teams, suppliers, consultants, and clinical stakeholders while mentoring less experienced engineers.
Requirements
- Bachelor’s degree in mechanical engineering with at least 7 years of relevant experience, or a master’s degree with at least 5 years, or a PhD with 3 years of engineering design and product development experience.
- At least 2 years of medical-device experience in spine, trauma, orthopedics, or dental applications.
- Proficiency with Creo, SolidWorks, or a comparable 3D CAD platform.
- Experience creating engineering drawings, applying GD&T, and performing tolerance stack analyses.
- Experience designing surgical instruments in a regulated product-development environment.
- Experience working with FDA, ISO, and Quality System Regulation requirements.
Nice to have
- Master of Science degree in Engineering.
- Experience with systems engineering, requirements traceability, verification, and validation.
- Knowledge of spinal anatomy, surgical procedures, and spinal technologies.
- Experience with Agile tools, Windchill, machining, additive manufacturing, and rapid prototyping.
Culture & Benefits
- Full-time regular employment with health, dental, and vision insurance.
- 401(k) plan with employer contribution and match, paid time off, and paid holidays.
- Health Savings Account, Flexible Spending Account, life insurance, and disability benefits.
- Tuition assistance, employee stock purchase plan, employee assistance program, and incentive plans.
- Eligible for the Incentive Plan and U.S. work authorization sponsorship because this is a Principal-level role.
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