Manager, Research and Development Planning and Innovation
Gyrus ACMI, Inc is a dynamic medical device company whose vision is to anticipate the needs of surgeons through powerful see and treat procedure solutions that are safe, simple, cost efficient and produce the highest quality patient outcomes. Gyrus ACMI is focused on Minimally Invasive procedures in Urology, Gynecology, General Surgery and ENT. Gyrus ACMI, believes its people are its greatest asset. We offer an environment that challenges everyone to grow, contribute, excel and share successes. Gyrus ACMI is committed to creating a world class company with world class people.
Position Description:
Southborough, MA - The Manager, Research and Development Planning and Innovation will be responsible for managing and executing related activities from a corporate perspective in the areas of the new product development process, planning, tracking and communication, the R&D technology development and strategic plan, and developing programs to enhance the capabilities of the R&D organization including education and training programs. EOE M/F/D/V
Requirements and Responsibilities:
* Manage and enhance the new product development process with a focus on ensuring new products are delivered to market specification, can be manufactured and perform to customer specifications in a reliable and consistent manner.
* Manage and enhance a technology development process that facilitates the technical growth of the organization with new and novel enabling technologies.
* Develop and implement enhancements to Gyrus' development methods and tools which will support innovation and continuous improvement of our entire new product development process.
* Track master plans for all of the group's development requirements. The master plan should reflect the business objectives of all the groups.
* Generate monthly reports for top Management on key metrics associated with the new product development process. Keep all parties informed on the status of specific development projects and ensure parties agree with status of project.
* Support the R&D Planning and Innovation mission as the unified voice of R&D with respect to strategic planning and tactical execution of new product development.
* Keep abreast of new developments, materials, or processes which can be used to improve the function or production of products and liaise with manufacturing sites.
* Follow GMP, ISO, FDA, and Gyrus operational procedures as required.
* Interact to some degree with almost every Gyrus department, including Research and Development, Sales, Marketing, Regulatory Affairs, Quality Assurance, Supply Chain, and Manufacturing.
* Maintain contact with clinicians, universities, labs, consultants, and vendors.
* Performs other related duties as assigned.
Qualifications:
(ONLY QUALIFIED CANDIDATES WILL BE CONSIDERED)
* A Bachelor's degree in Mechanical Engineering, Electrical Engineering, Chemical Engineering, Biomedical Engineering, or equivalent is required. A Master's degree is preferred.
* Project Management Institute PMP Certification is a plus.
* The following experience criteria are preferred. Exceptions to the criteria may be allowed for candidates that meet combinations of criteria or have additional exceptional skill sets:
- 8 years of product development experience, especially experience in medical device product development
- 3 or more years managing projects and cross-functional teams
- Experience in the design of disposable medical products
- Experience in the design, development, and tolerancing of complex medical products with continued exposure to the autoclave environment
- Experience working with multi-disciplinary teams
- Experience running multiple projects directly while managing other engineering resources running separate projects
- A working knowledge of applicable FDA and ISO standards
- Knowledge of engineering performance enhancement tools in the area of Design for Six Sigma (such as Voice of the Customer, Statistics, Design of Experiments, and Problem Solving)
* Effective leadership, motivational, and team building skills, with the ability to lead organizational change and demonstrated decision-making capabilities are essential.
* A sense of ownership and a desire to support the organization to achieve high-level corporate goals is necessary.
* Excellent written and oral communication skills and an attention to detail are required.
* Strong relationship skills with the ability to manage and motivate both up and down the organization are vital.
* Must have high energy, and be self-motivated, hands-on, and participatory with strong results orientation and the ability to quickly establish priorities.
* Full capability using Microsoft Applications including Word, Excel, Outlook, and PowerPoint is required. Capability using Microsoft Project is a plus.
* A working knowledge of Oracle is preferred.
* The following physical demands are required:
- Lift/carry 25 lbs
- Stand/sit/walk 8 hours per day
M1*
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