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R&D Project Manager/ FDA, Design
1 month ago
Position: R&D Project Manager/ FDA, Design
Location: Plymouth, MN 55442
Duration: 12 Months
Job Type: Contract
Work Type: Remote
Shift: Monday- Thursday 8 AM TO 4.30 PM
Pay Rate: $45-$53/hr
Overview:
TekWissen Group is a workforce management provider throughout the USA and many other countries in the world. Our client is a, passionate about improving and saving the lives of patients through high quality, innovative medical devices and services. A leading global manufacturer of specialty medical devices that provides innovative and lifesaving solutions for the world’s healthcare markets. Specializing in Infusion Therapy, Vascular Access, Vital Care, and Specialty Products & Services.
Job Description:
Qualifications:
Minimum Qualifications, Education & Experience
- Must be at least 18 years of age
- Bachelor’s degree from an accredited college or university is required
- 4+ years experience
Knowledge & Skills
- Detail oriented and ability to organize large amounts of work and data.
- Knowledge of project management methodologies and how to apply them.
- Familiar with design control concepts.
- Familiar with manufacturing processes and equipment.
- Experience working in an FDA regulated environment or other regulated industry preferred.
- Experience in functional areas: Hardware and Software Development, Quality, Medical, Commercial, Manufacturing Operations, Procurement, and Regulatory is preferred.
- Proficient in Microsoft tools (Project, Word, Excel, PowerPoint, Outlook, SharePoint)
- Work cooperatively and effectively with others to set goals, resolve problems, and make decisions that enhance organizational effectiveness.
- Assess situations to determine the importance, urgency and risks, and make clear decisions which are timely and in the best interests of the organization.
- Set priorities, develop a work schedule, monitor progress towards goals, and track details/data/information/activities.
- Assess problem situations to identify causes, gather and process relevant information, generate possible solutions, and make recommendations and/or resolve the problem.
Responsibilities:
Position Summary
- The Sr. Project Manager oversees the planning, implementation, and tracking of specific projects which have a beginning, an end and specified deliverables.
- The Sr. Project Manager will support the R&D Temperature Management business unit.
- The Sr. Project Manager will be expected to interface with multiple functional groups such as Marketing, Regulatory, Quality, Operations, R&D, Medical, Supply Chain and others at multiple sites.
- This role will support projects with an intermediate level of complexity.
Essential Duties & Responsibilities
- Facilitate project planning activities inclusive of budget, resourcing, and schedule.
- Collaborate with cross-functional managers to establish resourcing plans to the project schedule and budget.
- Responsible for executing the project(s) to the approved project plan.
- Develop, maintain, and document development plans through product development cycle.
- Lead teams to process improvements to enable effective decisions and outcomes.
- Communicate project risks effectively to key stakeholders.
- Comply with design control process and meet Quality Management System requirements.
- Accountability to lead the project team to successful completion of the project.
- Gather project feedback to drive continuous improvement.
- Accountable for the budget throughout the project lifecycle.
- Work on special assignments as they arise.
TekWissen® Group is an equal opportunity employer supporting workforce diversity.
