Manager, Case Planning

JOB SUMMARY

The Manager, Case Planning (Manager) is responsible for managing the case planning (CP) team and ensuring successful outcomes utilizing various 3D Pre-Operative planning products for commercial success. This role is responsible for building and managing a high performing case planning team. The Manager will lead the training and development of team members, delegate resources, create process improvements, and create a team structure to scale with our commercial needs. The Manager will also direct the case planning team and resources to ensure customer Case Plan vision is executed consistently, while maintaining metrics to foster continual improvement to the Case Planning function.

DUTIES & RESPONSIBILITIES

• Build and manage a high performing case planning team that meets the organization's current and future needs as our commercial business scales.
• Direct and assist with Case Planning activity through case planning team to support commercial case planning, clinical research projects, new product development and clinical trials.
• Develop and implement efficient customer case intake and production workflow for all THINK 3D pre-operative planning products.
• Partner with clinical launch specialist team to deliver best-in-class support for commercial case planning.
• Participate in and own complaint handling process for case planning team.
• Establish comprehensive didactic training programs for internal, external and distributor Case Planning Staff Roles.
• Solicit, record, and assess product feedback from Case Planner staff as well as end-user surgeons.
• Collaborate with product management for feature development, product pathways, and user needs.
• Conduct regular Jama (peer) reviews of Case Planning user needs/requirements, risk mitigations, and protocol validations.
• Develop HIPAA and GDPR compliance audit process, including ongoing monitoring across Customer Support department, reporting and escalating breaches to the Compliance Officer, and providing coaching/retraining as needed.
• Conduct weekly team meetings with Case Planning staff focused on production issues, project management and internal updates.
• Support internal and external lab case planning needs and logistics.
• Evaluate Case Planner staff performance in annual reviews. Create customized development pathways for CP staff to achieve performance goals
• Create and maintain all case planning work instructions, SOPs, and procedural documentation according to regulatory and FDA compliance.

SUPERVISORY RESPONSIBILITIES

• Direct and develop all case planners and support staff to build a high performance culture.
• Recruit, interview, hire, and train new staff in the department.
• Provide constructive and timely performance evaluation and feedback.
• Handle discipline and termination of employees in accordance with company policy.

QUALIFICATIONS

Required:

• Bachelor's degree and/or a minimum of 6-years of relevant work experience.
• A minimum of three (3) years' experience in clinical support with emphasis on preoperative planning of surgical procedures.
• Minimum of three (3) years of supervisory experience.
• Excellent project management and logistics acumen.
• Excellent verbal and written, interpersonal and presentation communication skills.
• Strong analytical skills, initiative, judgment and problem-solving ability.
• Must be able to demonstrate confidence under pressure, high level of product knowledge, and ability to make decisions quickly in high pressure setting.
• Highly proficient with Office 365 and other productivity software tools (including, but not limited to, MS office suite, Teams, and One Note, Adobe Acrobat, etc.)

• Knowledge of Good Manufacturing Practices (GMP) and applicable Quality System Standards.

Preferred:

• Advanced degree.
• Prior experience in the medical device industry, in particular orthopedics and/or surgical robotics.
• Prior experience with CT scan protocols, DICOM images and segmentation software.

COMPETENCIES

• Drives vision and purpose
• Decision quality
• Drives results
• Plans and aligns
• Problem solving
• Maintain confidentiality
• Being resilient
• Solutions Oriented
• Strategic Mindset
• Organizational Savvy
• Prioritization of business needs

PHYSICAL DEMANDS & WORK ENVIRONMENT

• Must be able to remain in a stationary position and operate office equipment for a prolonged period of time.
• Physical activities include, but not limited to constant manual dexterity, moving about the work site, and/or handling objects weighing up to 20 lbs.
• Other infrequent physical activities include, but not limited to, positioning self to complete assigned tasks, and ascending/descending floors and/or ladders.
• Occasionally work around moving mechanical parts.
• Must be able to work in a schedule that commensurate with business operation, including work during weekends, holidays and/or times outside of normal business hours.
• Must be able to travel as business necessitates (up to 5-10 %).

Disclaimer:

The above is intended to describe the general content of and requirements for the performance of this job. It is not to be construed as an exhaustive statement of duties, responsibilities, or physical requirements. Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time. Reasonable accommodations may be possible to enable individuals with disabilities to perform the essential functions.

THINK Surgical, Inc. ("THINK") is committed to hiring the best qualified candidates for approved positions while engaging in recruitment and selection practices that are in compliance with all applicable employment laws. It is the policy of THINK to provide equal employment opportunity for employment to all applicants and employees, regardless of any protected status. Any qualified applicant or employee with a disability who requires an accommodation in connection with their employment at THINK should contact Human Resources and request an accommodation. THINK also participates in E-Verify, a web-based system that allows THINK to confirm an employee's eligibility to work in the United States. Actual compensation offered will depend on several factors including but not limited to geographic location, work experience, education, skill level, and/or other business and organizational needs.