Medical Devices R&D Systems Engineer

Immediate need for a talented Medical Devices R&D Systems Engineer. This is a 12+months contract opportunity with long-term potential and is located in San Diego, CA (Onsite). Please review the job description below and contact me ASAP if you are interested.

Job ID: 25-73107

Pay Range: $60 - $65/hour. Employee benefits include, but are not limited to, health insurance (medical, dental, vision), 401(k) plan, and paid sick leave (depending on work location).

Key Responsibilities:

• Systems Engineering is responsible for using their technical expertise, collaboration and communication skills, and medical device development knowledge to drive R&D new product development and in market product milestones to completion.
• In this role, you are expected to translate voice of customer and stakeholder needs into system and product requirements, identify potential hazards and assesses requirements to ensure product compliance to safety and regulatory standards, drive product design architecture definition, proactively identify technical risks and mitigation pathways, lead and perform informal and formal system level requirement verification and user validation, and support engineering teams in developing design specifications for medical device systems with mechanical parts, electronics, software, and/or algorithms.
• The expectation for Engineer III, Systems Engineering is that they support the R&D function on project teams, demonstrate technical excellence, and strive for continuous improvement within the Systems Engineering function.
• As such, they are expected to drive their assigned R&D milestones to completion to ensure planned project milestones are met.
• Demonstrate knowledge of system-level medical device technology with mechanical parts, electronics, software, and algorithms
• Demonstrate knowledge of the medical device product development lifecycle and standards
• Ability to translate voice of customer and stakeholder needs into system and product requirements
• Responsible for coordination of aspects of system-level new product development and its integration
• Responsible for aspects of informal and formal system level requirement verification and user validation
• Lead aspects of system and product-level feasibility and risks assessments
• Facilitate cross-functional team knowledge sharing and experiences to promote the understanding and resolution of in-market and new product development issues
• Bring system level technical issues to resolution
• Identify potential hazards and associated risk control measures
• Demonstrate knowledge of clinical environments and clinical aspects of medical device usage
• Demonstrate or develop knowledge in signal processing and/or algorithm development
• Identify opportunities and drive continuous improvement efforts
• Apply experience in and best practices to experimental design and data analysis

Key Requirements and Technology Experience:

• Key Skills; Requirement gathering, Medical Devices Product Development, Statistical Data Analysis
• Must have a Bachelor s degree in Engineering.
• A post graduate degree is desired.
• 3 years related work experience (or combination of work experience and advanced degrees).
• A strong technical background and experience within systems engineering in the medical device industry (Translation of User/Business Needs to System Requirements, Requirements Management, System Architectural Development, Functional Modeling, Systems Integration, Statistical Test Design, Verification and Validation, Hazards Analysis, and Failure Modes Effects Analysis), and/or other engineering disciplines within the medical device industry, such as mechanical engineering, biomedical engineering, electrical engineering, or software engineering.
• Ability to work independently and as a member of a cross-functional medical device team.
• Ability to collaborate productively within multi-discipline engineering teams that may consist of mechanical engineers, electrical engineers, software engineers, biomedical engineers, and algorithm engineers to meet planned milestones.
• Excellent cross-functional communication skills, strong technical writing skills, attention to detail, and demonstrated ability to bring clarity to ambiguous areas to drive decisions.
• Demonstrated history of achievement, learning agility, and action orientation.
• Experience with medical device new product development.
• Hands-on experience with Design for Six Sigma and/or experience with experimental design and data analysis.
• Experience with signal processing and/or algorithm development is preferred, but not required

Our client is a leading Medical technology Industry and we are currently interviewing to fill this and other similar contract positions. If you are interested in this position, please apply online for immediate consideration.

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