Heart Institute Medical Device Engineering Manager (Makkar Group)

Job Description

Grow your career at Cedars-Sinai!

We reflect Cedars-Sinai's steadfast dedication to heart disease and research innovation giving patients access to the highest level of care. Year after year, thousands of people trust their hearts to Smidt Heart Institute at Cedars-Sinai. Our cardiologists, cardiac surgeons and niche care teams treat the full spectrum of heart disease and disorders, while our investigators continue to advance the field with groundbreaking, life-saving research. From genetic counseling and targeted drug therapies to a growing array of minimally invasive procedures, Cedars-Sinai continues to stand at the forefront of technology, innovation and discovery improving patient outcomes.

Join our team and use your skills with an organization known nationally for excellence in research!

This role will lead and make strategic decisions for a team of engineers, applying their technical expertise, leadership skills and deep knowledge of the medical device development process to drive and oversee innovation and concept phase projects. This individual will collaborate with both internal and external teams to make key decisions regarding the design and progress of new products, while also driving the establishment of intellectual property related to new product ideas and designs. With a strong understanding of technology capabilities, customer desirability, and financial viability, this individual will take ownership of shaping the process for product development, ensuring decisions align with broader business goals. The individual will manage multiple innovation opportunities in parallel, making decisions in the pursuit of incremental, architectural, disruptive and radical innovation.

Manages and makes critical decisions on all aspects of product design and development of implant and catheters in the neurovascular, structural heart, peripheral vascular, and endovascular specialties, ensuring alignment with clinical needs, market trends, quality standards, and regulatory requirements.

• Leads and advises a team of engineers and technicians throughout the entire lifecycle of product development, from ideation and design to prototyping, testing, and production, timelines, prioritization, and project priorities and scope in hopes to bring novel designs to first-in-human studies.
• Identify unmet implantable medical device needs in structural heart, endovascular and peripheral vascular space in collaboration with the PI and the Technology Ventures team. Provides clear direction to engineering team on developing high value-based patent ideas and identifying intellectual property opportunities.
• Defines and proposes actionable plans for domestic and international first in human studies, clinical and pre-clinical studies, to evaluate novel concepts.
• Coordinates and makes decisions to ensure priorities related to project budgets, timelines, and resources allocation are adhered to ensuring efficient and timely delivery of product achievements and final products, adjusting course when vital to meet strategic objectives.
• Leads critical communication and decision making with vendors/supplies and animal lab for pre-clinical trial proposals, ensuring that partnerships and collaborations align with business goals and timelines.
• Translate voice of customer and clinical needs as identified by the VP of Innovation into actionable decisions on concept storyboards, early-stage prototype concepts and system architectures. Prioritizes system/product requirements to drive project scope and operations, balancing project priorities and team capabilities.
• Provide updates and decision-making reports on technical progress of the team's efforts of the team to the VP of innovation, actively recommending adjustments to project priorities and timelines, if needed.
• Monitors progress and provides feedback of concept, technology feasibility and progress concepts/or technologies into new product development projects using bench testing and pre-clinical studies.
• Ensure compliance with medical device standards and leads all aspects of the preparation of technical documentation for regulatory submissions, and has authority to provide technical support for audits and regulatory inspections to maintain compliance.
• Leads decision making on improvement initiatives, drives opportunities for development processes improvements, and champions root cause investigations, corrective and preventative actions, and risk management strategies to mitigate risks.
• Collect, interpret, analyze and presents critical data on device performance and impact to the VP of innovation, making actionable recommendations for product improvement and strategic project adjustments

Qualifications

• Bachelor's degree in Biomedical Engineering, Mechanical Engineering, or related field. required.
• Postgraduate or Master's degree in Biomedical Engineering, Mechanical Engineering, or related field preferred.
• 15 year experience in medical device industry with concepts and product development
• 5 years Management/Supervisory experience coordinating all aspects of product lifecycle