Full Time

5 - 10 years

4 Year Degree

Project Manager position in a medical device company. The successful candidate will manage several projects around the company’s Stellaris product. These projects vary in nature from improvement projects to feature additions and include typically electrical, mechanical and software activities. The project manager is responsible for the cross-functional planning and scheduling of these projects, overseeing and tracking the execution using internal and external resources and delivering the results on time and on budget, under the company’s structured development process and regulatory mandates.

Job Duties:
Lead cross-functional project teams through all phases of a project towards successful completion: requirements development, planning, execution, verification & validation and launch.

Tracking project performance against plan with quantitative measures to ensure project goal attainment under FDA Design Controls and the B&L structured development process.

Prepare Statements of Work and manage outsourced activities.

Project Planning, using repeatable and accurate methods to accurately forecast schedules, resources needs, and project costs.

Communicate project status or project proposals to management.

Prepare annual budget plans and assist with the prioritization of projects. Prepare, review and revise budgets on a quarterly basis.

Qualifications:
Education: BS in a technical field required. PMI Certification strongly desirable.

Experience: 7+ years of project management in an environment with structured product development process. Must have medical device development experience and led cross-functional development teams. Established track record negotiating advantageous development contracts with 3rd party engineering suppliers.

Special Skills: Extensive experience with product development under a stage gated development process and FDA regulations. Working knowledge of Design for Six Sigma. Experience and knowledge of advanced planning and estimating as well as tracking tools. Excellent oral and written communication skills and demonstrated ability to lead cross-functionally.

Specialized Training: PMI Certification.

• BS degree or higher

• medical device experience

• project management experience

• contract negotiation

Frank Sinclaire - Health Care Division Group Manager fsinclaire@pailingroup.com

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