Sr. Manager of Research & Development
Company: Insight Global
Posted on: October 14, 2021
Insight Global is looking for a Sr. Manager of Research and
Development to run the new R&D Department for a Medical Device
company in Jacksonville, FL. This is the top R&D position for
the company in North America, and one which is expected to
significantly grow over the next few years. This position is
responsible to manage new product development projects, design
transfer, process development, as well sustaining changes within
current Design Controls maintained by the companys policies and
procedures. The position organizes and manages multiple projects to
ensure timely completion, utilizing creative solutions when issues
arise. The Senior Manager position includes direct management and
leadership of the entire R&D department at the company. The
Senior Manager must develop strong inter-departmental
relationships, and work with multiple departments both at the
company and the parent company, based in Germany. Responsibilities
With help of the Director of New Product Development and the
Executive team, establish and lead the Research and Development
department for the company
Conducts research and development projects associated with the
design and modifications of medical devices
Evaluation, support, and realization of feasibility projects.
Full Product development from feasibility to finished and approved
With coordination from key departments, help determine needed
testing and other key tasks to navigate thru the FDA approval
process for medical devices.
Ensures staff prepares or coordinates formal documentation of the
product Designs, Risk Analysis, Product Specifications, User Needs,
etc. according to established Design Control Procedures.
Responsible for remediation and updates of Design History Files,
Technical Files or other product registration efforts as
Ensures staff is trained to all current procedures and regulatory
requirements required for successful performance of their
Develops, maintains and publishes product Development Plans for
assigned projects with critical milestones and timelines.
Coordinates the product design and development process with
appropriate support departments such as quality, regulatory,
purchasing, product management, and manufacturing.
Assigns project leaders for assigned projects and responsible to
follow up on all aspects of projects, including reviews with
support groups and outside resources where applicable.
Ensures staff prepares or follows up on preparation of design
drawings, specifications, estimates of costs, system updates,
Discusses and consults with Product Management, clinical, etc. on
product requirements and specifications where design or
manufacturing problems are involved.
Works with manufacturing in the justification and the selection of
the manufacturing process, and assigns projects and establishes
priorities to ensure datelines and goals are achieved.
Enhances growth and development through participation in education
programs, professional development, industry conferences, current
literature, training meetings and workshops.
Mentor for junior level employees in the R&D Department.
Demonstrates professional responsibilities by cooperating with
other personnel to achieve department objectives and maintain good
employee relations, interdepartmental objectives, and departmental
goals and objectives.
Assist in the acquisition of needed equipment for the
Performs other related duties as assigned or requested.
Experience in additive manufacturing
Has started/revamped an R&D Department
Previous work with biomaterials (absorb into the body)
Experience with regulatory process/submissions (510(K))
5+ years experience with the medical device product development
process, to include regulatory submissions
o Avoid pharma. We want this person to have worked with
implants/Class II Devices
3+ years experience in a Project Lead and/or Leadership
o Managing ~ 5 people in the past Will manage 2 people to begin.
Department will grow to 25+
Experience with Specifications (design history files (DHF))
o Understand design controls, DHFs, etc.
Ability to manage and run Project Teams
BS in Engineering: Ideally Biomedical or Mechanical
Problem solving & Decision Making / Adaptability & Flexibility
High level of customer service & friendly/positive personality
Able to bring new ideas to the table
Exposure to SolidWorks or CAD Software
Travel requirements (up to 10% of travel)
Keywords: Insight Global, Jacksonville , Sr. Manager of Research & Development, Other , Jacksonville, Florida
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