Heart Institute Senior Medical Device Engineer (Makkar Team)
Apply NowCompany: Cedars-Sinai
Location: Los Angeles, CA 90011
Description:
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 work closely with other members of the research, design, and development team and will be responsible for department innovation's design and development of new implant and catheter products through development and oversight of technical processes, product changes and device improvements. Individual will collaborate closely with key collaborators (i.e. marketing, quality, operations, finance and clinical team) to support organizational growth and strategic goals related to innovative product design and development.
Develop, design, and improve prototyping for 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.
Qualifications
About Us
Cedars-Sinai is a leader in providing high-quality healthcare encompassing primary care, specialized medicine and research. Since 1902, Cedars-Sinai has evolved to meet the needs of one of the most diverse regions in the nation, setting standards in quality and innovative patient care, research, teaching and community service. Today, Cedars- Sinai is known for its national leadership in transforming healthcare for the benefit of patients. Cedars-Sinai impacts the future of healthcare by developing new approaches to treatment and educating tomorrow's health professionals. Additionally, Cedars-Sinai demonstrates a commitment to the community through programs that improve the health of its most vulnerable residents.
About the Team
Cedars-Sinai is one of the largest nonprofit academic medical centers in the U.S., with 886 licensed beds, 2,100 physicians, 2,800 nurses and thousands of other healthcare professionals and staff. Choose this if you want to work in a fast-paced environment that offers the highest level of care to people in the Los Angeles that need our care the most.
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 work closely with other members of the research, design, and development team and will be responsible for department innovation's design and development of new implant and catheter products through development and oversight of technical processes, product changes and device improvements. Individual will collaborate closely with key collaborators (i.e. marketing, quality, operations, finance and clinical team) to support organizational growth and strategic goals related to innovative product design and development.
Develop, design, and improve prototyping for 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.
- Collaborate with contract manufacturers to further develop products resulting from Cedars-Sinai internally developed prototypes and concepts.
- Collaborates with the Principal Investigator and lead engineer to carry out medical device needs in structural heart, endovascular and peripheral vascular space to develop value-based patent ideas and intellectual property.
- Applies software like abaqus, solidworks, creo, 3mensio, and mimics for computer aided design modeling of ideas.
- Plan and prepare quality system documentation specifications and detailed engineering drawings while developing new concepts to help support FDA submission and ensuring compliance for conducting first-in-human studies.
- Prepare and present sophisticated engineering design documentation, reports, and presentations to various collaborators and multi-functional teams, which may include clinical and research personnel, investors and regulatory bodies.
- Prove concept and technology feasibility and progress concepts and/or technologies into new product development through bench studies and animal studies.
- Prepare and submit regulatory reports for compliance (i.e. FDA 510(k) and PMA submissions) to the regulatory bodies including FDA to facilitate early human use of products post development.
- Drive continuous improvement initiatives and finds opportunities to improve product designs and streamline development processes. Participate in root cause investigations and corrective and preventative actions and implement risk management processes and tools to mitigate risks.
- Design and implement testing protocols to evaluate the performance, safety, and durability of products.
Qualifications
- Bachelor's degree in Biomedical Engineering, Mechanical Engineering, or related field required.
- 10 years Experience in medical device industry with concepts and product development required.
- 5 years project management experience overseeing aspects of product life cycle.
About Us
Cedars-Sinai is a leader in providing high-quality healthcare encompassing primary care, specialized medicine and research. Since 1902, Cedars-Sinai has evolved to meet the needs of one of the most diverse regions in the nation, setting standards in quality and innovative patient care, research, teaching and community service. Today, Cedars- Sinai is known for its national leadership in transforming healthcare for the benefit of patients. Cedars-Sinai impacts the future of healthcare by developing new approaches to treatment and educating tomorrow's health professionals. Additionally, Cedars-Sinai demonstrates a commitment to the community through programs that improve the health of its most vulnerable residents.
About the Team
Cedars-Sinai is one of the largest nonprofit academic medical centers in the U.S., with 886 licensed beds, 2,100 physicians, 2,800 nurses and thousands of other healthcare professionals and staff. Choose this if you want to work in a fast-paced environment that offers the highest level of care to people in the Los Angeles that need our care the most.