Sr. R&D Product Development Engineer (Medical Device)
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 risk management process of combination products during development in accordance with ISO 14971 and relevant FDA guidance as the designated risk SME.
- Oversee and document risk management activities using tools such as FMEA and risk summary reports.
- Lead a multidisciplinary team of mechanical, electrical, software, quality and regulatory SMEs in risk analysis process ensuring all inputs are captured accurately and efficiently.
- Document Deign Inputs and linkage between the Marketing Requirements, Standards Reviews, Risk Management, User Requirements, Technical Requirements.
- Follow FDA Design Controls process.
- Document Design Outputs and show traceability to Design Inputs with Trace Matrix (Product Requirement Matrix).
- Responsible for assuring all Risk and Requirements documentation is compliant with 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.
- Collaborate with Sustaining Engineering, New Product Introduction, and Quality to facilitate change, and resolve new or existing product requirements issues.
- Keep manager advised of all work status, workload, problems, and progress as related to work assignments.
- Ensure development activities are following QMS, OSHA, local, state and federal environmental regulations.
- Improve processes and procedures to develop high quality products at a minimum cost.
- Exhibits regular, reliable, punctual and predictable attendance.
- Performs other duties as assigned based on business needs.
- Proven experience in risk management
- Education: Bachelor's in Mechanical, Biomedical, Material Science, or related Engineering field.
- At least 5-8 years of experience in design control in the medical industry.
- 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.