Program Manager (Medical Device R&D)

We are looking for an experienced Program Manager to lead challenging multi-disciplinary development projects and integration efforts. Your job will be to coordinate the efforts of cross-functional teams to ensure that our programs are delivered on time and produce the desired results. As a core team leader, you will drive everything involving the program’s overall organization and timeline. Specific responsibilities will include developing detailed project plans, accounting for resource availability and allocation, communicating regular program updates, and delivering each program iteration on time within budget and scope. The candidate should have a background in program leadership, technical R&D / development and project planning & execution. You should be an excellent communicator, and comfortable managing multiple tasks. You also need to be a team player and have a problem-solving aptitude.

Essential Duties and Responsibilities

• Support and advocate basic PMO principles and processes such as driving strict schedule management, using proper change control to manage scope, ensuring proper requirements, and actively managing risks throughout the program.
• Execute the duties as Program Manager for the development of capital medical devices used in spinal fusion procedures.
• Ensure the preparation of program timelines and thoroughly communicate deliverables, dependencies, changes, decisions, and rationales.
• Challenge the core team to meet aggressive but reasonable schedules. Be creative in dealing with obstacles and keeping the team on track.
• Maintain continuous grasp of your program’s changing schedule and scope
• Perform ongoing, active risk management to minimize project risks
• Quickly and thoroughly communicate any issues and escalate to management as needed
• Manage the relationship between all cross functional stakeholders including Engineering, Verification and Validation, Marketing, Regulatory, Quality, etc
• Work with Marketing to clearly define and communicate the product roadmap so the core team can prioritize and plan future resources.
• Ensure the creation and maintenance of comprehensive project documentation

Requirements

The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Ability to lead and provide direction to a cross-functional core team
• A collaborative style that fosters teamwork and successful project results while reinforcing company culture
• Drive results and provide updates in a manner that creates confidence in the core team
• Ability to foster consensus when possible but also flex to make difficult decisions when necessary
• Solid technical background, with understanding or hands-on experience in systems engineering, electrical engineering, software development and /or web technologies
• Systemic thinker who can see across multiple functions to holistically identify secondary effects and risks.
• Strategic thinker who anticipates and nurtures opportunities and priorities
• High degree of initiative, problem-solving and ownership
• Timely and accurate Project Scheduling / Planning, Tracking & Status Reporting with ability to hold teams accountable and mitigate potential timeline delays
• Ability to manage multiple projects in a rapidly evolving environment
• Be focused on customer requirements and supporting positive patient outcomes, able to balance technical and business needs while maintaining a positive, professional outlook.

Education and Experience

• Bachelors Degree from a four-year college or university (or equivalent), preferably in the fields of Computer Science or Software, Systems or Engineering
• At least 5 years experience in R&D / New Product Development with an emphasis in Project Management in a regulated environment (preferably medical devices) is required.
• Proven track record of successfully leading multiple new product development efforts through the entire cycle, from concept to launch.
• Experience with integrated hardware and software medical devices.  
• Practical working knowledge of:
• ISO 13485 / 14971 / 62304
• FDA / MDD / CE
• IEC 62304 / 62366
• Design Controls / Design History File
• Requirements Definition
• Risk Management
• Validation & Verification
• Strong working knowledge of Microsoft Office
• Familiar with Microsoft Project or other project management software
• PMP / PRINCE II certification is a plus 
• Agile, Scrum, and Jira experience a plus

For roles based in the United States that require access to hospital facilities, must be eligible for and maintain credentials at all required hospitals, including meeting any applicable physical requirements or vaccination requirements (including the COVID-19 vaccine, as applicable).

ATEC is committed to providing equal employment opportunities to its employees and applicants without regard to race, color, religion, national origin, age, sex, sexual orientation, gender identity, gender expression, or any other protected status in accordance with all applicable federal, state or local laws. Further, ATEC will make reasonable accommodations that are necessary to comply with disability discrimination laws.

Salary Range

Alphatec Spine, Inc. complies with state and federal wage and hour laws and compensation depends upon candidate’s qualifications, education, skill set, years of experience, and internal equity. $140,000 to $160,000 Full-Time Annual Salary Range