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Sr. Manager of Research & Development

Company: Insight Global
Location: Jacksonville
Posted on: October 14, 2021

Job Description:

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 include:

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 medical device.

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 required.

Ensures staff is trained to all current procedures and regulatory requirements required for successful performance of their positions.

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, etc.

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 department.

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 position

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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