Engineering Project Manager

1 day ago

Madison, United States Indotronix Avani Group Full time

Summary

Reporting to the Director of Engineering, the Technical Project Manager will be an engineering professional, responsible for leading technical projects through planning, scheduling, budget management, resource management for change control, and stage gate projects in alignment with the department’s SOPs in a matrix of cross-functional groups. Leads and delivers projects as a project management expert. Will be responsible for project planning and management along with all activities needed for product development projects under design controls. Develops mechanisms for monitoring project progress and for intervention and problem-solving through collaboration with other technical team members. Ensures project results meet requirements regarding technical quality, reliability, schedule, and cost. Integrates with the project teams and facilitates discussions on technical and nontechnical problems throughout the life of the project. Oversees and coordinates work performed by outside contractors. Provides timely, and accurate information and status updates to project stakeholders and management. Participates in budget development and evaluating how project plan changes impact cost, resource requirements, and schedule.


Main Responsibilities:

• Provides leadership and centralized management for the planning, developing, and executing technical projects to achieve critical strategic business objectives. Manages multiple, often concurrent projects and consistently meets expectations.

• Competent in, making difficult decisions regarding priorities among projects/programs while ensuring the buy-in of teams and leaders.

• Manages and is responsible for all phases of project execution including stage gate reviews, design reviews, etc.

• Leads the project team members in using established PM tools and techniques to stay within authorized budget limits and achieve the overall project and organizational objectives.

• Competent in conducting risk assessments for technical and project-related issues and developing mitigation plans to ensure project schedule and costs are maintained.

• Innovator and forward thinker. Leads and contributes to the development of Madison Engineering and Operations organization thru innovative thinking and application of technical knowledge.

• Develops methods, procedures, and metrics for projects (scope, schedule, quality, and cost) and reporting. Monitors and controls implementation plan by defined scope.

• Responsible for the successful execution of significant technical projects. Through proper planning, ensures that scope, schedule, cost, and customer expectations are met. Maintains a clear focus on life cycle costs.

• A technical / engineering background in Medical Device product development and sustaining engineering within the medical device sector.

• Fosters an environment of innovation in others, integrating experiences from multiple disciplines to develop solutions that meet the business objectives.

• An understanding of medical device regulations including FDA standard 21 CFR Parts 820, design controls, ISO13485, regulatory, audits and international environmental regulations. Experience and track record of success in the development of 510K/PMA-regulated medical products required.


Job Requirements:

• A minimum of 3 years experience and a proven track record in:

o Applying project management tools to manage Product Development Projects

o Applying project management tools to manage Engineering Projects

o Building, managing, and maintaining business partnerships.

o Applying knowledge of ISO standards and FDA Design Control regulations

• Experience in the development of complex sophisticated software controlled electromechanical medical devices with verification & validation activities is a plus.

• Experience in outsourced medical device manufacturing, manufacturing technologies, and process development is a plus.

• BS in engineering or technical field with 3+ years of product development (medical device engineering) and 3+ years of applicable project management experience in medical devices, healthcare, or pharma development environments.

• Possesses interpersonal skills to negotiate and reconcile differences, while optimizing overall business goals

• Excellent written and verbal communication skills with strong competency in MS Office tools and Project management applications.

• Certification in Process Excellence (Green Belt or Black Belt) or project management certification PMP is a plus.

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