A top tier global medical device company located in St. Paul, MN is currently seeking a Project Manager of R&D Engineering to join their R&D engineering team.
General Job Overview:
This role would be for project manager of R&D engineering focusing on new product development in compliance with US, EU, Japan and other country regulatory and MOH agencies. The project manager would manage cross-functional teams to accomplish the tasks necessary to assure that the overall project goals are delivered on time, within budget, and all performance requirements are met.
You must be able to work with marketing, sales, finance, regulatory, operations and upper management to refine the customer requirements, budgets and prioritization of projects. This position suits an individual who is passionate about making healthcare breakthroughs to advance the overall patient care around the world.
- Lead the strategic planning, initiation, execution, and launch of new products and product extension
- Must have experience with medical device development, 21CFR 820.30 and ISO 13485 at a minimum
- Create an environment where team members feel free to speak and know that their concerns will be addressed
- Defines and develops a project plan, schedule, resource requirements, hazard analysis, project cost estimates, and other required documents.
- Work with cross functional team to establish comprehensive design inputs and requirements sets. Work with marketing to establish required voice of customer evidence.
- Assure that the product requirements have been met through testing and analysis.
- Resolve problems that arise during development.
- Critically evaluate existing processes, identify inefficiencies, recognize opportunities and optimize, where necessary
- Track project expenses and product cost and performance against scheduled milestones.
- Resolve resources issues and project conflicts between team members and the organization.
- Some domestic travel may be required.
- Other duties as assigned by the supervisor.
- B.S. degree in Engineering, Chemistry, or Science field is required
- Minimum of 7 years of product life cycle experience with demonstrated success leading medical device/clinical drug development products
- Expertise in all aspects of project management with the ability to manage multiple priorities and projects
- PMP experience is desired
- Understanding of drug and/or device development processes, Quality Management Systems, Good Manufacturing Practices, Good Laboratory or Clinical Practices, and applicable regulations
Interview process for this position would involve telephone call with hiring manager and a final on site interview.
Sthree US is acting as an Employment Agency in relation to this vacancy.