TeDan Surgical Innovations (TSI) design and manufactures specialty surgical products for use in spine, neuro, thoracic, and orthopedic surgeries.
TSI was founded in 2006 with the goal to innovate and address evolving retraction techniques in spine surgery. We have successfully addressed the need for minimally invasive, posterior, lateral and anterior surgical approaches to the spine, and have introduced access instrumentation for neurological, orthopedic and cardiothoracic procedures. We commit to providing innovative, high-quality surgical access systems designed to optimize exposure and improve the surgeon experience.
Job Summary:
The Project Manager will oversee and manage projects within the business. The ideal candidate will have a strong background in project management and a deep understanding of the medical device industry. This role is crucial in ensuring that projects are completed on time, within budget, and to the highest quality standards while adhering to regulatory requirements. You will design the project goals and success markers, determine how success will be measured and tracked and ensure the project remains on time and on budget while motivating team members to hit their goals. Project Managers also act a liaison between the project team and upper level management. You will be expected to prepare and present progress reports and ensure the project is furthering organizational goals.
Duties/Essential Job Functions:
Develop comprehensive project plans, including scope, schedule, budget, and resource allocation.
Define project objectives, deliverables, and key performance indicators (KPIs).
Coordinate cross-functional teams to ensure successful project execution.
Manage project timelines, ensuring that milestones and deadlines are met.
Monitor and control project budgets, ensuring cost-effective use of resources.
Ensure all project activities comply with internal operating procedures, relevant regulatory standards (e.g., FDA, ISO), and customer requirements.
Serve as a point of contact for external customers.
Provide regular updates and status reports to Engineering Management and other key stakeholders.
Identify potential project risks (such as resource constrains, budget overruns, timeline delays, etc.) and develop mitigation strategies.
Address and resolve issues that may arise during the project lifecycle.
Evaluate project outcomes and implement improvements to enhance future project performance.
Foster a culture of continuous learning and best practices within the team.
Awareness of General TSI Quality Management System (QMS), Good Documentation Practices (GDP), Good Manufacturing Practices (GMP), and Complaint Handling through annual TSI Training
Knowledge/Skills:
Strong understanding of medical device development processes, regulatory requirements, and industry standards.
Proven track record of successful projects.
Exceptional verbal and written communication skills, with the ability to effectively engage with diverse internal and external stakeholders.
Good task and time management skills with the ability to manage multiple projects simultaneously.
Proven ability to identify and resolve complex issues and challenges.
Ability to use Microsoft Office (Word, Powerpoint, & Excel).
Excellent project management, organizational, and leadership skills. Proficiency in project management software (e.g., MS Project)
Required Minimum Education/Experience:
Bachelor's degree in business, marketing, life science, or engineering (science, medical technology, biomedical engineering) or similar areas.
Advanced degrees or certifications (e.g., PMP, Six Sigma) are a plus.
3+ years professional experience in medical device industry.