Sr. Manager of R&D
Company: Kelly Science, Engineering, Technology & Telecom
Location: Torrance
Posted on: June 19, 2022
Job Description:
Sr. Manager of R&D - Direct HireKelly Engineering Resources
is hiring a Sr. Manager of R&D for a premiere client in
Torrance, CA. This is a Direct hire opportunity where you will be
part of an advanced medical device company dedicated to the
research, development and commercialization of a miniaturized
implantable ventricular assist system featuring total magnetic
suspension for the treatment of end-stage chronic heart failure.
With offices in the US and China, we are growing our US team in
preparation for clinical studies and regulatory approval in the US
and EuropeWhat You Will Need for this Sr. Manager of R&D
Position:
- B.S. or higher degree in Biomedical Engineering or related
field
- 10+ years of experience as an R&D Manager
- 10+ years of industrial experience in Class III medical device
R&D, regulatory approval, and commercialization
- MUST HAVE Ventricle Assist Device (VAD) experience
- VAD experience is critical, class 3, project management, would
be open to people who have worked with other heart devices if not
VAD exp, exp with Management-they will manage a team of 6.
- Extensive experience in project management and team
management
- Extensive experience in working with regulatory bodies,
research institutes, CROs, clinicians, vendors, and outside
consultants
- Extensive experience in implantable medical device design,
testing, manufacturing, documentation, and problem solving
- Proficient in medical quality management systems 21 CFR Part
820 ISO 13485
- Comprehensive familiarity with ISO 14708, IEC 60601 and other
medical device standards
- Excellent interpersonal and technical communication skills
- Ability to work in a dynamic global environment with multiple
changing priorities
- -20% domestic and international travelAdditional to have:
- Remote with some travel, if you are based in Southern CA or
Florida, will look at candidates in Washington or Mid West, Travel
at least once a month.
- Don't need to be fully vaccinated
- M-F, 1st shift, 8-5 or 9-6 occasionally evening calls with
ChinaWhat you will be doing:
- Lead US R&D team
- Work with leadership on the company's new product strategy
- Establish development plans for new products and line
extensions
- Ensure timely completion of new product development projects in
compliance with regulatory
- standards.
- Support company AOP and budget
- Provide training, coaching, and mentorship to team members
- Support QMS and design controls including specification, risk
analysis, design history files, etc.
- Identify potential design issues and solutions in compliance
with FDA, ISO and other
- requirements
- Interact with regulatory bodies and lead FDA applications
- Interact with clinicians and CROs and lead U.S clinical
trials
- Support regulatory inspections/audits and timely resolution of
CAPAs
- Support smooth technology transfer and commercial scale-up
- Execute the vision and strategy for the organization
- Drive a culture of creativity and innovation#TJP2022_SPEC,
#R&D, #researchanddevelopment, #manager, #VAD
Keywords: Kelly Science, Engineering, Technology & Telecom, Torrance , Sr. Manager of R&D, Executive , Torrance, California
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