Program Manager RandD

Spacelabs Healthcare; Hyderabad; On-site; INR 2,500,000 - 4,000,000; Full time

Job summary

Spacelabs Healthcare is seeking a Program Manager to lead a portfolio of hardware and software development programs. You will enforce best practices, ensure customer-centric delivery, and mentor the team while adhering to company policies and regulatory requirements.

You will collaborate with product management, sales, marketing, and clinical teams, manage requirements and schedules, and drive risk analyses. Travel up to 10% is expected for global coordination.

Qualifications

• Bachelor degree in Engineering or CS; Master’s preferred.
• 5+ years in software-driven medical device development per IEC 62304.
• 5+ years hardware-driven medical device development incl. design transfer.
• 5+ years program management on complex NPD.
• FDA/regulatory knowledge desirable.
• PMP or PMI-ACP certification preferred.
• Willingness to travel up to 10%.

Responsibilities

• Provide leadership to an interdependent family of programs and projects.
• Collaborate with product management, sales, and clinical teams to understand customer needs.
• Manage requirements, specifications, schedules, and risk analyses.
• Prioritize features and improvements with Change Review Board and plan.
• Develop detailed project plans with MS Project and Azure DevOps.
• Improve processes for planning, execution, and refinements of program increments and sprints.
• Lead 3rd party vendors for manufacturing of medical devices.
• Ensure delivery meets regulatory requirements (FDA, CSA, EU, CFDA) and QMS.
• Build and support teams, set expectations, and provide status updates.
• Negotiate schedules, risks, features, and resource trade-offs.

Skills

Leadership

Communication

Stakeholder management

Regulatory knowledge

PMI PMP / PMI-ACP

Education

Bachelor's degree in Engineering or CS

Master’s degree desirable

Tools

MS Project

Azure DevOps

Job description

Job Description

Overview

The Program Manager leads hardware and software development projects. They are responsible for enforcing best practices within the teams, ensuring delivery of customer-centric products while enforcing adherence to company policies and procedures, and compliance requirements, while mentoring and growing the skill set of the team.

Responsibilities

• Provide leadership and umbrella guidance to an interdependent family of programs and projects.
• Work with product management, sales, marketing, and clinical teams to understand the needs of our customers.
• Manage product requirements, functional specifications, schedules, and risk analyses for programs and projects.
• Work with product management and the Change Review Board to prioritize features and technical improvements and build these into the planned product.
• Program Planning – Collaborates with stakeholders (engineering and test teams, product managers, and senior leadership, etc.) to define the scope, objectives, and deliverables of the projects/program. Develop detailed project plans (MS Project and Microsoft Azure DevOps), taking into account resource availability, timelines, and budget constraints.
• Manage and continually improve the process for planning, execution, and refinements for Program Increments, Sprints, and the overall project schedule.
• Manage the development of required plans and documentation for all development activities.
• Lead 3rd party vendors for manufacturing of medical devices.
• Lead teams to deliver on the plan, with a constant focus on delivering high-quality products that meet customer expectations; follow the Spacelabs QMS; and are fully compliant with government regulations across our customer base, including FDA, CSA, EU, CFDA, and others.
• Build, drive, and support teams through the development process. Set expectations and lead project delivery skill-building among team members.
• Eliminate barriers, elevate issues as appropriate, and provide visibility into development status for other stakeholders. Provide frequent communications and formal project reviews with program team, and others as required.
• Negotiate schedule, risk, product features, and resource trade-offs with project and program teams.
• Uphold the Company’s core values of Integrity, Innovation, Accountability, and Teamwork.
• Demonstrate behavior consistent with the Company’s Code of Ethics and Conduct.
• Ensure that direct report(s) are trained and evaluated on their knowledge and adherence to the company’s values, Code of Ethics and Conduct, and applicable compliance policies.
• It is the responsibility of every Spacelabs Healthcare employee to report to their manager or a member of senior management any quality problems or defects in order for corrective action to be implemented and to avoid the recurrence of the problem.
• Duties may be modified or assigned at any time to meet the needs of the business.

Qualifications

• Bachelor of Science degree in Engineering, Computer Science, or a similar related degree. Master’s degree is desirable.
• 5+ years’ experience in software-driven medical device development compliant with IEC 62304
• 5+ years’ experience in hardware-driven medical device development, including design transfer to manufacturing.
• 5+ years’ experience in program management
• 5+ years’ experience in managing complex interdependent new product development projects within demanding timeframes required. Solid understanding of the development process, including requirements gathering, analysis and design, development tools and technologies, release and version control, contemporary testing methodologies, and deployment management.
• Knowledge of FDA and medical device regulatory and registration requirements or work in a similarly regulated industry is desirable.
• Demonstrated track record of encouraging innovation and out-of-the-box thinking.
• Proven ability to deliver results through others, both in direct and matrixed organizational models.
• Proven ability to lead dedicated, passionate teams, including an ability to motivate and hold others accountable – including international teams
• Excellent communication and negotiation skills, for both internal and external audiences, at all levels.
• Experience in specifying and shipping software for use in cloud environments is highly desirable.
• Knowledge of and ability to work within a global corporate environment is required.
• Must travel internationally and be able to acquire all necessary travel documents. Travel up to 10%.
• PMI – PMP or PMI-ACP Certification.

Physical Requirements

• Standing: 0%-5%
• Bending: 0%-5%
• Sitting: 70%-75%
• Stooping: 0%-5%
• Reaching: 0%-5%
• Walking: 0%-5%
• Lifting: (0 – 25lbs or 25 – 50lbs)
• Use of computer: 90%
• Must be able to complete job responsibilities in an environment with global time zone needs, such as attending late-night/early-morning meetings by phone and/or web to meet global business needs.