The Project Engineer – Disposable Product Line is responsible for managing some of the company’s external development projects. He/she will be leading and working amongst a cross-functional team with the goal of developing product upgrades and/or new products for the companies’ disposable product line as well as managing disposable supplier transfer projects.
The ideal candidate will be an experienced and proactive Project Engineer with medical device industry knowledge and experience; he/she is a skilled communicator and problem-solver with the ability to delve into details with the engineering teams while providing clear and concise summaries to the management team.
- Oversees and manages ongoing projects and serves as liaison between external design teams and internal cross functional team. Activities would include:
- Project initiation including coordination of initial business plans, regulatory and clinical strategy and design inputs definitions
- Project execution including but not limited to design, design verification and validations, manufacturing validations
- Project release activities including registrations, launch activities, etc
- Create and manage project plans including work breakdown structures, budget, GANTT/timeline, project risk identification and mitigations.
- Regular status reporting for the team and leadership, communicate with leadership on status, risks, needs for project execution
- Technically review the design, design documentation, qualifications etc from the external design team. Provide technical guidance and directions as needed.
- Lead transfer of DHF and Technical Files from the external team into the organization
- Ensure alignment of all stakeholders throughout the project phases
- A minimum of 3 years’ experience in project management within the medical device industry; PMP designation preferred
- Medical device industry experience, experience with design and development of sterile devices preferred
- A university degree in Engineering or Biomedical Engineering preferred
- Strong technical writing capability and excellent oral communication skills.
- Highly organized with well-developed time-management skills and processes for managing multiple priorities
- Highly developed analytical and quantitative skills.
- Negotiation skills and the ability to comprehend and integrate new information rapidly to create successful outcomes. Strong leadership and team-building skills required
- Motivated self-starter with an ability to determine when to act and when to ask for support.
- Experience with FDA820.30 and ISO 13485
- Ability to travel up to 25%
- Fluent in English required
If you meet the above requirements, please email your resume and cover letter to email@example.com.
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