MDR - Implementation Project Lead

MDR - Project Lead (MDR engineering team)
100% REMOTE
Duration: 24 Months+
Pay Range $50-$60/hr on w2

HM is looking for:
The Hiring Manager is seeking an MDR Project/Program Manager/Lead with medical or clinical experience. The ideal candidate will have PMP certification (a strong plus) and a background in Manufacturing Engineering or Quality Engineering. A Bachelors degree in Life Sciences, Biomedical, or Mechanical Engineering is required. Candidates with 25 years of relevant experience will be considered.


TECHNICAL SKILLS

Must Have

• 0-3 years of medical / clinical experience or exposure

• Project Management

Nice To Have

• EU MDR Project Implementation

• PMP

HM's Top Needs:

1. Project Lead/Management experience

2. Medical devise or pharmaceutical/biotechnology background

3. Background in manufacturing engineering or Quality engineering

Education Required: Bachelors degree in life science, Biomedical, Mechanical, Industrial or Quality Engineering, Business Administration

Years Experience Required: +2 years

MDR implementation project manager:

Responsibilities may include the following and other duties may be assigned. Supports one or more Cardiac Surgery MDR project across functional and regional organizations. Coordinates all facets of the project(s) from intake through implementation and closure. Accountable for the successful implementation of the outcomes the MDR implementation projects, MDR remediation assignment, etc.

Focus on finding resolution, planning and control, change and prioritization of the projects deliverables at Grand Rapids. Ensures the project adheres to all Corporate and IT policies and standards. Responsible for effectively managing the site constraints: Schedule all label verification activities with operation and help support the MDR engineering team to review and complete the change orders related to these activities. Provides technical and analytical guidance and recommendations to project managers of Grand Rapids projects. Keeps current on advances and best practices in project management methodologies.

SPECIALIST CAREER STREAM:
Typically, an individual contributor with responsibility in a professional discipline or specialty. Support projects assigned as site MDR project lead and works with other stakeholders to achieve desired results. The majority of time is spent delivering and organising site related deliverables and other aspect of the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University) and/or experience and skills.

DIFFERENTIATING FACTORS

Autonomy:
Established and productive individual contributor. Works independently with complete alignment with project managers and MDR Implementation program manager to strategize, implement and complete all the related adeliverable. Work of complex projects / assignments.

Organizational Impact:
Sets objectives for own job area to meet the objectives of projects and assignments. Contributes to the completion of project milestones. May have some involvement in cross functional assignments.

Innovation and Complexity:
Problems and issues faced are general and may require understanding of broader set of issues or other job areas but typically are not complex. Adjusts or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area.

Communication and Influence:
Communicates primarily and frequently with project managers and regularly report out the activities progress of the projects. External interactions with suppliers, PO generation, etc. if necessary. Contacts others to share information, status, needs and issues to inform, Product input, and support decision-making.

Required Knowledge and Experience:
Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with experience.
Requires a University Degree and minimum of 4 years of relevant experience, or advanced degree with 2 years of experience. MDR experience is prefered.