R&D Program Manager – Enterprise Software

🕒 August 28

🇺🇸 United States – Remote

💵 $103.6k - $176.4k / year

⏰ Full Time

🟠 Senior

🔴 Lead

📋 Program Manager

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

👻 Ghost score 8%

What it means: the chance that no one is really hiring for this job.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.Why this score:

• Open for 76 days.
• Jobs at this company usually fill in 47 days.

Apply Now

Find Similar Remote Jobs

Haemonetics

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 1980

🏥 Healthcare

💼 Consulting

🏭 Manufacturing

Healthcare • Consulting • Manufacturing

Haemonetics is a company that provides a suite of innovative medical technology solutions aimed at improving the quality, effectiveness, and efficiency of healthcare. The company focuses on optimizing operations for plasma centers, enhancing patient care in hospitals, and driving efficiency in blood centers by offering advanced technologies that improve productivity, quality, and safety. Haemonetics is committed to advancing healthcare standards and creating better outcomes for patients through their technology and services.

📋 Description

• Plan, execute, and manage Enterprise Software projects according to strict deadlines and within budget • Manage program risks, critical paths, costs, schedules, scope, resources, and multiple integrated projects • Engage resources and coordinate team members and third-party organizations to deliver projects according to plan • Lead complex software development programs for medical device products in regulated environments • Ensure compliance with FDA, ISO 13485, IEC 62304, cybersecurity, and Quality Management System requirements throughout the software development lifecycle • Manage programs involving on-premises and cloud-based software platforms, coordinating architecture, infrastructure, validation, deployment, and release activities • Analyze program risks, assess business impact, develop mitigation strategies, and lead programs from concept through commercialization • Create and execute project plans, adjusting scope, schedules, and resources as needed • Manage day-to-day program operations and ensure compliance with Stage-Gate processes, quality systems, and SOPs • Partner with Software Engineering, Quality, Regulatory Affairs, Cybersecurity, Product Management, Clinical, and Operations teams • Drive continuous improvement using Lean, Six Sigma, and other operational excellence methodologies • Establish and monitor program metrics, KPIs, and dashboards • Coordinate software verification, validation, traceability, documentation, and release readiness activities • Ensure deployment, implementation, and commercialization plans address customer-hosted and cloud-hosted environments • Lead process standardization initiatives and streamline workflows • Use project and portfolio management tools to maintain and communicate schedules, milestones, dependencies, and status • Establish governance structures for alignment, accountability, and decision-making • Maintain accountability for Design History File deliverables, regulatory requirements, and QMS compliance • Capture lessons learned and drive adoption of best practices

🎯 Requirements

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

🏖️ Benefits

• 401(k) with up to a 6% employer match and no vesting period • Employee stock purchase plan • Flexible time off for salaried employees • Three to five weeks’ vacation annually for hourly employees, based on tenure • Up to 64 hours annually of paid sick time • Paid and/or floating holidays • Parental leave • Short- and long-term disability insurance • Tuition reimbursement • Health and welfare benefits • Discretionary annual bonus for non-sales roles • Potential eligibility for the Company’s long-term incentive plan

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume