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Program Manager (Medical Device R&D)

Program Manager (Medical Device R&D)

ATEC SpineCarlsbad, California, United States
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We are looking for an experienced Program Manager to lead challenging multi-disciplinary development projects and integration efforts. You will be a core team leader coordinating cross-functional teams to ensure that our programs are delivered on time and produce the desired results. You will plan, execute, and manage the program’s overall organization and timeline. Specific responsibilities 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 management, core team leadership, and technical R&D / development. Experience should include successful project planning, execution, and delivery of programs / products on time and on schedule. You should be an excellent communicator and comfortable managing multiple tasks. You are collaborative, build consensus, but can lead and make key decisions when necessary. You are curious and creative in addressing obstacles.

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 regularly communicate deliverables, dependencies, changes, decisions, and rationales at core team meetings.
  • Challenge the core team to meet aggressive but reasonable schedules.
  • Maintain continuous grasp of your program’s changing schedule and scope
  • Perform continuous, active risk management to minimize and anticipate 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.
  • Coordinate with System Engineering and Regulatory on the creation of controlled documents required for 510k
  • Other duties as assigned.

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.

  • Previous experience leading core teams and directing cross-functional teams
  • Managed the development of medical devices, capital equipment preferred
  • Solid technical background, with understanding or hands-on experience in systems engineering, electrical engineering, software development, materials, or cloud technologies
  • History of dealing with controlled documents in a regulatory environment, FDA / Medical preferred
  • 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
  • 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 using project scheduling tools 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, or Manufacturing
  • At least 5 years experience in R&D / 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 from concept to development 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

    • 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

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