SENIOR PROJECT MANAGER ** Medical Diagnostic Devices
Chek Diagnostics, a medical diagnostic device manufacturer, is hiring a Sr. Project Manager in Indianapolis, IN.
- Are you a results-oriented, hands-on leader?
- Can you process driven with a flair for product development?
- And, would you thrive in an entrepreneurial, energetic company that is experiencing consistent growth?
At Chek Diagnostics, we take great pride in delivering industry-leading point-of-care and home diagnostics to the global health care market. Our focus is the development of diagnostic tests for chronic diseases such as heart disease, diabetes, and other related medical conditions.
With 30% annual growth and strong profitability, we have committed to the ongoing development of innovative products for the early diagnosis and the ongoing management of these diseases; we take the business of supplying the highest quality, most technologically advanced tools possible very seriously. Founded in 1992, Chek Diagnostics is headquartered in Indianapolis, Indiana, USA. Our products are represented in more than 100 countries worldwide.
As our Sr. Project Manager you will develop and improve efforts for the CardioChek system, which encompasses new product developments, sustaining engineering, and maintenance operational support systems. Reporting to the Head of Quality, remain alert to compliance situations with regulatory requirements of the quality system documentation. Adopting a “quality in everything we do” approach, you will manage medical diagnostics project direction, coordination, implementation, execution, control and completion while ensuring consistency with company strategy, commitments and goals.
- Lead the planning and implementation of major projects.
- Facilitate the definition of project scope, goals, and deliverables.
- Develop full scale project plans and define project tasks and resource requirements.
- Develop project objectives by reviewing proposals and plans.
- Determine project specifications by completing technical studies, preparing cost estimates, and studying product design, customer requirements, and performance standards.
- Confirm product performance by designing and conducting tests.
- Determine project schedule by monitoring project progress, coordinating activities, and resolving problems.
- Control project costs by approving expenditures and administering contractor contracts.
- Prepares project status reports by collecting, analyzing, and summarizing information and trends.
- Bachelor of Science degree or higher in scientific (chemistry, biochemistry) or engineering discipline.
- Qualification in project management or equivalent (PMP, MPM).
- At least 5 years’ experience in medical diagnostics or medical device industries.
- Knowledge of both theoretical and practical aspects of project management.
- Direct work experience in project management capacity, managing both internal and external complex projects.
- Proven experience in people management and cross functional teams and in strategic planning.
- Proven experience in risk and change management.
- Working and applied knowledge of FDA design control and ISO 13485 product realization requirements for medical devices.
- Experience in new product development form early conception through production launch.
- Ability to function in a high impact position within a fast-paced, deadline driven environment.
- Strong analytical and technical skills to assess situations and drive decision-making.
COMPENSATION AND BENEFITS:
Chek Diagnostics will reward your talents with a generous salary plus possible incentive opportunity. You will also receive a generous benefits package including medical benefits, dental, flexible medical spending account, life insurance, LT disability, PTO, and 401(k) retirement plan with company match.
If you are an influencing and leading manager, we encourage you to apply online now. We prefer that you submit an electronic resume via this career site.
To learn more about Chek Diagnostics, please visit www.cardiochek.com.
Chek Diagnostics requests that all candidate and recruiter inquiries be directed to Safari Solutions.
Drew Smith, HR Consultant
Keywords: life sciences, diagnostic, health products, medical devices, diagnostic, diagnostic devices, healthcare, lipids, cholesterol, Roche, Lilly, chemical, chemistry, quality, engineering, technology, advance manufacturing, plant, SPC, automation, packaging, equipment, operational software, electronics, biomedical, electrical, computer science, Indianapolis, project management, FDA, ISO, risk management, PMP