This position was created to supervise, track, and analyze R&D projects, under the direction of the VP of R&D. In addition, the Project Engineer is expected to be the primary approver/owner of non-complex alternative raw materials qualification and oversee ongoing stability testing as needed to support assigned projects. The Project Engineer will have direct responsibility for the R&D project management system including assembling teams and facilitating team meetings, updating progress, managing the critical path of assigned projects, author supporting validation and protocol documentation in congruence to governing Quality System and regulatory requirements, assist the VP of R&D in resource management and contribute to achieving other departmental objectives.
- Collaborating with cross-functional teams to bring product ideas from feasibility to launch
- Developing timelines, milestones, and tracking budgets of new projects
- Assist in building of a research team and creative, focused, and positive environment that can successfully take products from concept to completion
- Coordinate in-house trials of new product concepts, submit samples for clinical/quality testing and analyze results
- Conduct analysis on new raw material or alternative materials to be used in wound care products
- Generate reports and design records, present results to team
- Perform required validations for product design file
- Compose design files, master device records for product launch
- Organize, manage and direct project team tasks and assures proper application of Design Control standards, tools and methodologies in project work.
- Identify and assemble project team(s) and provides leadership and mentoring to assure effective project completion
- Delivers full project objectives on time and on budget
- Responsible for maintaining current and complete project management data and documents in professional project management software package
This position reports to the VP of R&D Department.
- BS in chemistry/biology or related fields
- MS or Certification in Project Management preferred
- 3 to 5 years of experience in medical device/pharmaceutical industry with emphasis on product development
- Proven track record in project management and multiple phases of product development; must be able to manage multiple projects at the same time
- Experience with FDA in 510(k) submissions and relevant knowledge of national and international quality and regulatory issues related to medical devices
- Project management experience along with knowledge of statistical/mathematical tools for data analysis
- Excellent communication/report writing skills
- Working knowledge of FDA Quality System Regulation, ISO 13485/9001 and ISO 14971 regulatory standards for medical devices
- Excellent time management skills
- Must demonstrate the ability to set and meet deadlines
- Manage multiple, larger or cross-divisional projects at one time (projects can be of high risk level and typically involve cross-divisional coordination)
EuroMed Inc. is an international medical device manufacturing company that was founded in 1991 in Fredensborg, Denmark. In 1997, it moved...