MDR – Prin R-D Engineer – Exempt

Planet Pharma; Irvine (CA); On-site; USD 69,000 - 96,000; Full time

Job summary

Planet Pharma is seeking an experienced senior engineer to lead design activities for Neurovascular medical devices. You will design and redesign medium to high complexity devices, mentor teammates, and collaborate with Sustaining and NPD functions to ensure compliance and performance.

Responsibilities include designing experiments, documenting results, and contributing to IP and regulatory pathways while maintaining safety and quality in all projects.

Qualifications

• Bachelor’s degree and 10+ years engineering experience in a related field.

Responsibilities

• Design and redesign Neurovascular medical devices and subsystems across medium to high complexity.

Skills

Engineering experience

Medical device experience

Neurovascular knowledge

Clinical/regulatory knowledge

CAPA management

Problem solving

Mentorship

Leadership

Education

Bachelor’s degree in polymer science, engineering, scientific, or technical discipline

Tools

Catheter development

Design control

Job description

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
• 10+ 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.

Target pay $50-70/hr based on experience level