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11 days old

Sr. Manager of R&D

Kelly Services
Torrance, CA 90509
**Sr. Manager of R&D Direct Hire**


Kelly Engineering Resources is hiring for 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 Europe


**What 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 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 travel


**Additional 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.

+ Dont need to be fully vaccinated

+ M-F, 1st shift, 8-5 or 9-6 occasionally evening calls with China


**What you will be doing:**


+ Lead US R&D team

+ Work with leadership on company 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**



**Why Kelly** **** **?**


Your engineering skills are in demand, but how do you find the right fit? Easy. With Kelly Engineering, our experts connect you with leading organizations where you can learn and grow, collaborate on innovative projects, and keep your skills sharp with top technology. Whether you prefer the variety and flexibility of short-term projects, or are looking for something more long-term, were here every step of the way to find your dream engineering job.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.

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Posted: 2022-06-17 Expires: 2022-07-18

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Sr. Manager of R&D

Kelly Services
Torrance, CA 90509

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