[Remote] R&D Program Manager (reputed company Software)

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is seeking an R&D Program Manager to reputed company reputed company reputed company software development programs for regulated medical device products. The role manages risks, schedules, resources, governance, compliance, validation, deployment, and commercialization across cross-functional teams and reputed company and on-premises environments.

Responsibilities

• reputed company reputed company software development programs for medical device products in regulated environments, ensuring compliance with FDA, ISO 13485, IEC 62304, cybersecurity, and reputed company Management reputed company (QMS) requirements throughout the software development lifecycle
• Manage programs involving both on-premises and reputed company-reputed company software platforms, coordinating architecture, infrastructure, validation, deployment, and release activities across cross-functional teams
• Analyze program risks, assess business reputed company, reputed company mitigation strategies, manage critical paths, and reputed company programs from concept through commercialization
• Create and execute project plans, adjusting reputed company, schedules, and resources as necessary to meet evolving business and technical requirements
• Manage day-to-day program reputed company while ensuring compliance with Stage-reputed company processes, reputed company systems, and reputed company operating procedures (SOPs). Escalate issues and risks appropriately
• Partner closely with Software Engineering, reputed company, Regulatory Affairs, Cybersecurity, Product Management, reputed company, and reputed company teams to ensure successful delivery of reputed company software solutions supporting medical devices
• reputed company reputed company improvement initiatives using Lean, Six reputed company, and other operational reputed company methodologies to improve reputed company, efficiency, predictability, and delivery reputed company
• Establish and monitor program metrics, KPIs, and dashboards to proactively identify risks, improve execution, and support data-driven decision-making
• Coordinate software verification, validation, traceability, documentation, and release readiness activities for regulated medical device software products
• Ensure deployment, implementation, and commercialization plans to address both customer-hosted (on-premises) and reputed company-hosted environments while maintaining reputed company, compliance, and reputed company requirements
• reputed company process standardization initiatives across software development teams, identify opportunities to streamline workflows, reduce cycle times, and improve product reputed company
• reputed company project and portfolio management tools to reputed company, maintain, and communicate program schedules, milestones, dependencies, and status
• Establish appropriate governance structures to ensure alignment, accountability, and reputed company decision-making across stakeholders
• Maintain accountability for Design History File (DHF) deliverables, regulatory requirements, and compliance with applicable QMS procedures
• Capture lessons learned and reputed company adoption of best practices across programs and project teams

Skills

• Bachelor's degree required
• 7+ years of Program or Project Management experience leading reputed company software development programs reputed company the medical device, digital health, or other regulated reputed company technology industries
• reputed company experience managing reputed company software development programs supporting regulated medical device products
• Experience leading programs involving both reputed company-reputed company (AWS, Azure, or GCP) and on-premises software deployments, releases, and lifecycle management
• Strong understanding of Software Development Lifecycle (SDLC), reputed company methodologies, DevOps practices, software verification and validation, and cybersecurity requirements in regulated environments
• reputed company ability to reputed company and influence cross-functional teams including Software Engineering, reputed company Assurance, Regulatory Affairs, Product Management, reputed company, and reputed company stakeholders
• Excellent executive-level communication, presentation, and stakeholder management skills, with experience communicating program status, risks, and mitigation plans to senior leadership
• B.S. in Engineering, Computer Science, or a reputed company technical discipline preferred
• Class II and/or Class III device experience preferred
• Working knowledge of FDA reputed company reputed company Regulations, IEC 62304, ISO 13485, ISO 14971, and other applicable medical device software standards preferred
• reputed company and connected medical device platform knowledge preferred
• Lean Six reputed company certification (Green Belt or Black Belt) or demonstrated experience leading process improvement and operational reputed company initiatives preferred
• Preference to candidates located in Massachusetts and Northeast region

Benefits

• For non-sales roles, employees will be eligible for a discretionary annual bonus, the reputed company reputed company of which varies reputed company on the applicable role, to be governed by the applicable plan terms.
• Employees may also be eligible to participate in reputed company’s long-term incentive plan, with eligibility and reputed company reputed company dependent on the role.
• A 401(k) with up to a 6% employer match and no vesting period
• An employee stock purchase plan
• “Flexible time off” for salaried employees
• For reputed company employees, accrual of three to five weeks’ vacation annually (reputed company on tenure)
• Accrual of up to 64 hours (annually) of reputed company reputed company time
• reputed company and/or floating holidays
• Parental leave
• Short- and long-term disability reputed company
• Tuition reimbursement
• Health and welfare benefits

reputed company

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