R&D Program Manager (Enterprise Software)

haemonetics; United States; On-site; USD 104,000 - 176,000; Full time

Benefits offered by this job

401(k) matching up to 6%

Employee stock purchase plan

Flexible time off for salaried; 3–5 wk

Paid holidays

Sick time

Parental leave

Disability insurance

Tuition reimbursement

Health and welfare benefits

Job summary

Haemonetics is seeking a Program Manager to lead complex software development programs for medical device products in regulated environments, coordinating on-premises and cloud platforms, and ensuring compliance with FDA, ISO 13485, IEC 62304 throughout the lifecycle.

You will partner with Software Engineering, Quality, Regulatory Affairs, Cybersecurity, Product Management, Clinical, and Operations to deliver enterprise software solutions, manage risks, timelines, and budgets, and drive lean

Responsibilities

• Lead complex software programs for medical devices in regulated environments, ensuring compliance with FDA/ISO 13485/IEC 62304.
• Manage on-premises and cloud software programs, coordinating architecture, validation, deployment, and releases with cross-functional teams.
• Analyze risks, assess impact, develop mitigations, manage critical paths, and lead programs from concept to commercialization.
• Create and execute project plans, adjusting scope, schedules, and resources to meet evolving requirements.
• Manage day-to-day operations while ensuring Stage-Gate, quality systems, and SOP compliance; escalate risks.
• Collaborate with Software Eng, Quality, Regulatory, Cybersecurity, PM, Clinical, and Ops to deliver enterprise software for medical devices.
• Drive continuous improvement with Lean/Six Sigma to improve quality, efficiency, and delivery.
• Establish and monitor program KPIs and dashboards to identify risks and support data-driven decisions.
• Coordinate V&V, traceability, documentation, and release readiness for regulated medical device software.
• Plan deployment/implementation for on-prem and cloud while ensuring security, compliance, and quality.
• Standardize processes across dev teams to streamline workflows and improve quality.
• Use PM tools to develop and communicate schedules, milestones, dependencies, and status.
• Establish governance structures for alignment and decision-making.
• Maintain accountability for Design History File (DHF) deliverables.

Job description

Pay Transparency

The pay range for this role is:

$103,600.00-$176,400.00/Annual

The base pay actually offered to the successful candidate will take into account, without limitation, the candidate's location, education, job-knowledge, skills, and experience in prior relevant roles.

Incentives may also be provided as part of Haemonetics' employee compensation. For sales roles , employees will be eligible for sales incentive (i.e., commission) under the applicable plan terms. For non-sales roles , employees will be eligible for a discretionary annual bonus, the target amount of which varies based on the applicable role, to be governed by the applicable plan terms. Employees may also be eligible to participate in the Company's long-term incentive plan, with eligibility and target amount dependent on the role.

In addition to compensation, the Company offers a competitive suite of benefits to its employees, including without limitation:

• 401(k) with up to a 6% employer match and no vesting period


• employee stock purchase plan


• \"flexible time off\" for salaried employees and, for hourly employees, accrual of three to five weeks' vacation annually (based on tenure)


• accrual of 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

Depending on your location, you may be eligible for more detailed information related to the compensation and benefits related to this job posting. If you believe you may be entitled to such information by law, you may contact 1-781-348-7777, Monday through Friday, 7:30 a.m. - 5 p.m. ET or email [e-mail].

We are constantly looking to add to our core talent. If you are seeking a career that is challenging and rewarding, a work environment that is diverse and dynamic, look no further - Haemonetics is your employer of choice.

Job Details

The Program Manager is responsible for planning , executing , managing risk, managing critical paths and commercializing Enterprise Software projects according to strict deadlines and within budget. This includes engaging resources and coordinating the efforts of team members and third-party organizations to deliver projects according to plan. Accountable to create project team governance to engage in cross functional accountability of costs, schedules, scope, resources and track risks of programs and multiple integrated projects. Preference to candidates located in Massachusetts and Northeast region.

As a Program Manager the candidate will:

• Lead complex software development programs for medical device products in regulated environments, ensuring compliance with FDA, ISO 13485, IEC 62304, cybersecurity, and Quality Management System (QMS) requirements throughout the software development lifecycle.


• Manage programs involving both on-premises and cloud-based software platforms, coordinating architecture, infrastructure, validation, deployment, and release activities across cross-functional teams.


• Analyze program risks, assess business impact, develop mitigation strategies, manage critical paths, and lead programs from concept through commercialization.


• Create and execute project plans, adjusting scope, schedules, and resources as necessary to meet evolving business and technical requirements.


• Manage day-to-day program operations while ensuring compliance with Stage-Gate processes, quality systems, and standard operating procedures (SOPs). Escalate issues and risks appropriately.


• Partner closely with Software Engineering, Quality, Regulatory Affairs, Cybersecurity, Product Management, Clinical, and Operations teams to ensure successful delivery of enterprise software solutions supporting medical devices.


• Drive continuous improvement initiatives using Lean, Six Sigma, and other operational excellence methodologies to improve quality, efficiency, predictability, and delivery performance.


• 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 cloud-hosted environments while maintaining security, compliance, and quality requirements.


• Lead process standardization initiatives across software development teams, identify opportunities to streamline workflows, reduce cycle times, and improve product quality.


• Leverage project and portfolio management tools to develop, maintain , and communicate program schedules, milestones, dependencies, and status.


• Establish appropriate governance structures to ensure alignment, accountability, and clear decision-making across stakeholders.


• Maintain accountability for Design History File (DHF) deliverabl