Engineering Project Manager

Automated Systems, Inc.

Job Description

This Engineering Project Manager  will work under R&D leadership to lead the EU MDR remediation project(s) for the Advanced Surgery Global Business Unit product portfolio to support EU registrations through the relevant notified bodies for maintenance and MDR submissions.

Responsibilities:
• Create and maintain remediation project schedules
• Identify resources needed and secure resource allocation, with leadership help, as needed
• Lead remediation team meetings, maintain risks and issues list(s)
• Recognize issues and develop solutions with the team to keep project(s) on track
• Manage projects on a cross functional basis, including direct supervision of team members.
• Manage the project costs (all financial aspects) of product development. This will include capital expenditures and cross functional expenses.
• Support preparation for meetings with stakeholders to report status and present issues for decision-making
• Own the labeling remediation process
• Support the cross-functional content review of the clinical evaluation related deliverables

Hybrid work location: Remote to Deerfield, IL keep in mind post COVID the job location may be required to be in office a few days





Requirements

Education / Experience:
• Minimum of a completed Bachelors of Science in the following disciplines: Mechanical, BioMedical, or Science.
• Minimum of 3-5 years of project management experience.
• 5-8 years experience in device product development (sustaining or New Product Development)
• Software skills: Excel and MS Project; also, Word, PowerPoint, SharePoint, One Drive, Outlook
• Medical Device industry experience required
• Must have experience with multiple projects in parallel
• Thorough, up to date knowledge of multiple disciplines required.

Qualifications:
• Experiences coordinating medical device projects working cross-functionally with contributing disciplines.
• Understands key processes, including product development documentation, change control, labeling, clinical evaluation and post-market surveillance.
• Able to organize across multiple initiatives and integrate work streams into a cohesive project.
• Communicates effectively with team and stakeholders with appropriate levels of detail and escalates effectively, when needed.
• Independent judgment in the evaluation, selection and adaptation of various engineering techniques required.


Job Requirements

Education / Experience: • Minimum of a completed Bachelors of Science in the following disciplines: Mechanical, BioMedical, or Science. • Minimum of 3-5 years of project management experience. • 5-8 years experience in device product development (sustaining or New Product Development) • Software skills: Excel and MS Project; also, Word, PowerPoint, SharePoint, One Drive, Outlook • Medical Device industry experience required • Must have experience with multiple projects in parallel • Thorough, up to date knowledge of multiple disciplines required. ​ Qualifications: • Experiences coordinating medical device projects working cross-functionally with contributing disciplines. • Understands key processes, including product development documentation, change control, labeling, clinical evaluation and post-market surveillance. • Able to organize across multiple initiatives and integrate work streams into a cohesive project. • Communicates effectively with team and stakeholders with appropriate levels of detail and escalates effectively, when needed. • Independent judgment in the evaluation, selection and adaptation of various engineering techniques required.

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