Sr. R&D Systems Engineer (Medical Device Product Development )
The Sr. R&D Systems Engineer will support design and development activities of medical devices for proprietary products under development at the R&D site. This role has frequent interaction with R&D Engineering, Product Sustainment Engineering, Quality, Marketing, Regulatory Affairs and other key functions to achieve business deliverables. The individual will bring excellent analytical, engineering, and organizational talent to the execution of development projects.
location: Scottsdale, Arizona
job type: Permanent
salary: $95,000 - 100,000 per year
work hours: 9 to 5
- Lead, implement and execute system engineering tools and processes within the R&D group.
- Lead design control process of combination products throughout product life cycle in accordance with relevant standards and FDA guidance.
- Participate in cross-functional teams for defining system design and performance requirements specifications while applying in-depth knowledge of design control of combination products.
- Mentor and guide younger system engineers.
- Provides a "Customer Service" attitude when interacting with internal and external customers while accomplishing work, production, and achieving quality standards.
- Oversee risk management activities using tools such as FMEA and risk summary reports.
- Oversee and document design inputs and linkage between the marketing requirements, standards review, risk management, user requirements and technical requirements.
- Oversee and execute the documentation of design outputs and show traceability to design inputs with trace matrix (Product Requirement Matrix).
- Responsible for assuring all design control process and documents follow the QMS.
- Implement Systems Engineering best practices for methodology, attend Systems Engineering training, and conduct necessary training for R&D staff as methodology is established.
- Lead engineering and general design review as required.
- At least 3-5 years of experience in design control in the medical industry.
- Proven experience in risk management.
- Education: Bachelor's in Mechanical, Biomedical, Material Science, or related Engineering field.
- Must have excellent communication skills.
- Must have interpersonal skills.
- Background in R&D of Combination product.
- Background in R&D of electromechanical medical device.
- Knowledge of ISO-11608, IEC-60601, IEC-62304 is an advantage
skills: Medical Device Product Development
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.