Technical Project Manager

Description: Job Summary:

WHK BioSystems is seeking a skilled Technical Project Manager to lead the planning, execution, and delivery of technical projects focused on the development and production of single-use systems and components. This role will bridge engineering, manufacturing, and quality teams to ensure projects meet customer specifications, regulatory requirements, and company standards. The ideal candidate will bring technical expertise in bioprocessing or medical device manufacturing and a proven ability to manage complex projects in a fast-paced environment.

Essential duties and responsibilities include the following. Other duties may be assigned:

Oversee end-to-end project management for custom single-use assemblies, from design concept to full-scale production, ensuring on-time delivery within budget and scope.

Collaborate with cross-functional teams, including engineering, injection molding, extrusion, and cleanroom assembly, to define project goals, timelines, and deliverables.

Develop and maintain detailed project plans, including resource allocation, risk assessments, and schedules.

Serve as the primary liaison between internal teams and external clients or vendors, providing clear communication on project status, challenges, and milestones.

Ensure compliance with customer-specific requirements throughout the project lifecycle.

Coordinate the integration of WHK manufacturing processes into project workflows, optimizing efficiency and quality.

Identify and resolve project roadblocks, leveraging problem-solving skills to maintain momentum and meet deadlines.

Drive process improvements by capturing lessons learned and refining project management practices for future initiatives.

Provide injection molded manufacturing technical support when appropriate

Support the transition of R&D concepts into scalable production solutions, balancing innovation with practical manufacturing constraints.

Teamwork is essential for TSE's continued success, so Teamwork is an essential function of every employee's job. Teamwork drives positive results every day. Teamwork promotes positive customer relations and results in exceeding the expectations of our customers. Teamwork benefits every employee since it grows our business and increases our sales. With Teamwork, we all succeed. Without it, we all suffer. Teamwork with co-workers in the same department is just the beginning. Teamwork with every other employee, department and division is the Teamwork that is required to succeed. WE ARE TSE.

Requirements: Qualifications:

Bachelor's degree in engineering, biomedical sciences, or a related technical field.

5+ years of project management experience, with at least 3 years in a technical role within bioprocessing, medical device manufacturing, or a related industry.

Demonstrated success in delivering projects involving custom manufacturing, preferably single-use systems or components.

Knowledge of biopharmaceutical fluid management, injection molding, or tubing extrusion processes is highly desirable.

Familiarity with ISO 13485:2016, FDA regulations, and cleanroom manufacturing standards.

Strong organizational and leadership skills, with the ability to manage multiple stakeholders and priorities.

Proficiency in project management tools (e.g., MS Project, or similar) and Microsoft Office Suite.

Excellent communication skills, with experience interfacing with technical teams and clients.

Ability to adapt to a dynamic, customer-driven environment while maintaining a focus on quality and efficiency.

Travel Requirements: Up to 50%

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