Sr. Program Manager (PM)
- Santa Barbara, CA
- Full Time
True Digital Surgery is a World Leader in Computer-Guided Microsurgery. We combine 3D visualization and guidance software applications focused on improving accuracy, efficiency and outcomes for surgeons and patients. Our medical imaging and guidance system employs advanced real-time 3D graphic capabilities and proprietary software that is sold to surgeons and hospitals all over the world.
The Sr. Program Manager (PM) leads multidisciplinary teams for assigned programs/projects utilizing program management techniques in a highly regulated medical device environment. This position is primarily focused on the timely execution of New Product Development in accordance with the Quality Management System (QMS), partner contracts and product specifications. In addition to New Product Development, the PM will also lead continual product or business process improvement initiatives.
The selected individual will need to be a technical leader with the ability to make direct technical progress assessments within Systems, Electronics, Mechanical, Optical, Software, Manufacturing and Test Engineering disciplines. The PM will have the responsibility of representing the organization in a highly professional manner and will need to prepare and present partner facing communications, documents and presentations. These communications will be with external stakeholders such as partners, critical and/or strategic suppliers and contract manufacturers (CMs) as well as internal stakeholders such as Engineering, QA, Regulatory Affairs, Operations, Purchasing, Customer Service and the True Digital Surgery Senior Management team.
ESSENTIAL DUTIES AND RESPONSIBILITIES
Include the following. Other duties may be assigned.
- Responsible for development and execution of project plan with clear milestones and deliverables to ensure timely completion of projects within established timeline and budget
- Ensure project compliance with Contracts, Specifications and Quality Management System (QMS) for medical devices
- Applies and demonstrates technical management and organizational skills that results in a collaborative culture using clear, credible, objective and proactive communications and stakeholder management
- Lead regular team meetings in an efficient manner with cross functional team members including engineering, operations, purchasing, quality, regulatory, customer service, partners, critical suppliers and contract manufacturers
- Track and document the project progress, monitors the risks, effectiveness, and performance of the project and project team and proactively facilitates the development of contingency plans and recommended corrective actions as required
- Publish project documentation
- Action item tracking and task prioritization
- Appropriately manage / escalate project issues or risk
- Prepare and conduct monthly program reviews with senior management
- Prepare and conduct quarterly program reviews with partners (as required)
- Participate in the development and improvement of policies and procedures and tools that affect efficient program management and product development
- All other duties as assigned by the VP, Operations and Program Management
- Occasional travel may be required
- 10+ Years’ experience with MS Degree in Engineering (preferably EE in high tech sector)
- 15+ Years’ experience with BS Degree in Engineering (preferably EE in high tech sector)
- 7+ years of program or project or technical leadership experience with demonstrated past performance of successfully transitioning a product through the following development gates: proof of concept, development, verification, test, manufacturing build, commercial launch and service
- 2+ years of experience with Quality Management Systems (QMS) for medical device manufacturers
- Advanced skill set with MS Office (Word, Excel, PowerPoint), MS Project, Visio, Confluence, JIRA
SPECIALIZED JOB KNOWLEDGE
To excel in this position, an individual would benefit from the following competencies.
- Complete understanding and application of Program Management principles, concepts and industry best practices in a highly regulated medical device field
- Proficient systems engineering approach to technical problem-solving skills
- Full knowledge of medical device industry standards and design control: 21CFR820, ISO 13485 QMS, IEC60601 Safety, Essential Performance and EMI/EMC
- Basic familiarity and operation of surgical microscopes
- Familiarity with robotics
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this Job, the employee is regularly required to sit; use hands to finger, handle, or feel; reach with hands and arms and talk or hear. The employee must occasionally lift and/or move up to 50 pounds and frequently lift and/or move up to 10 pounds. Specific vision abilities required by this job include color, distance and close vision.
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is frequently exposed to work near moving mechanical parts. The noise level in the work environment is usually moderate.
We value our employees’ time and efforts. Our commitment to your success is enhanced by our competitive compensation and an extensive benefits package including paid time off, medical, dental and vision benefits and future growth opportunities within the company. Plus, we work to maintain the best possible environment
To respond to this opportunity, please apply through this ad.
For more information about us, please visit www.truedigitalsurgery.com
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.