Principal R&D Development Engineer

Primary Talent Partners has a new contract opening for a Principal R&D Development Engineer  with our medical device client in Irvine, CA. This is a 6-month contract with a potential for extension.


Pay:$70.00 - $90.00/hr; W2 contract, no PTO, no Benefits. ACA-compliant supplemental package available for enrollment. Candidates must be legally authorized to work in the United States and must be able to sit on Primary Talent Partners W2 without sponsorship.


Description:
As a Principal R&D Development Engineer, you will design and develop life-saving medical device products. Key responsibilities include product development, conducting product testing and creating models and prototypes. You will work under general direction in a project role and may serve as key functional core team member and/or leadership role in an extended team. The product focus will be on neurovascular catheters.
  

Key Responsibilities:

• Design and redesign medium to high complexity Neurovascular medical devices and subsystems.
• Supports programs led by Sustaining and NPD functions
• Test and optimize the design by designing and conducting relevant experiments and evaluations including numerical verification.
• Prepare full documentation in accordance with relevant internal SOPs and Design Control.
• Participate in pre-clinical in vivo labs, observing cases in hospitals and through planned and unplanned customer interactions.
• Create and evaluate prototypes to generate concept and model approvals.
• Write engineering reports and create presentations as required to document and communicate results.
• Prepare reports, presentations and spreadsheets of an analytical and interpretative nature.
•  Institute design changes based on internal and external customer feedback.
• Collaborate with peers to manage the development of appropriate testing to verify product meets internal and external customer requirements.
• Maintain accountability to the completion of specific programs and projects in accordance to agreed project deliverables.
• Contribute inventions, new designs and techniques regarded as advances in the medical and technical/scientific community.
• Use advanced techniques to anticipate, identify and develop solutions or alternatives to a variety of common and uncommon problems having a range of complexity.
• Provide leadership, training and mentorship to less experienced team members.
• Demonstrated ability to manage and prioritize multiple tasks/projects with a strong problem solving ability.
• Adhere to safety policy procedures.

 

Qualifications:

• Bachelor's degree in polymer science, Engineering, scientific, or technical discipline
• 0+ years of engineering experience
• 6+ years of medical device experience
• Thorough understanding of Neurovascular medical device industry and competitor products. Working knowledge of other related disciplines.
• Thorough understanding of clinical and regulatory pathways, IP and internal processes.
• Experience with design remediation and CAPA management
• Demonstrated ability to take initiative in keeping current with technology developments in specialized area.
• In depth knowledge and wide application of technical principles, theories, and concepts in related field of expertise to develop innovative approaches to work
• In-depth clinical knowledge for uses of product.
• In-depth knowledge of Neurovascular anatomy relative to surgical procedures for specific products. 
• Ability to effectively communicate and work cooperatively with others as a lead member of a team.
• Demonstrated experience sharing information, status, needs, and issues with others in order to inform, gain input, and support decision-making.
• Expertise in catheter development and related processes.
• Equipment and tooling design.

 

Preferred qualifications:

• Experience with Neurovascular products 
• Experience designing catheters and guidewire systems
• Experience with metal process (braiding, coil, laser cutting, etc.) and polymer (extrusion, injection, blending, etc.) process, characterization and testing. Understanding on the process and property correlations.

Must Have Skills:

• Catheter Design and Development
• Catheter testing
• Failure Analysis and Root Cause Investigation
• Polymer Material Science

Primary Talent Partners is an Equal Opportunity / Affirmative Action employer committed to diversity in the workplace. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, age, national origin, disability, protected veteran status, gender identity, or any other factor protected by applicable federal, state, or local laws.

If you are a person with a disability needing assistance with the application or at any point in the hiring process, please contact us at info@primarytalentpartners.com

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