R&D Program Manager (Enterprise Software)

Pay Transparency:

The pay range for this role is:

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, 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 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, and/or 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 [email protected].

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 Manageris responsibleforplanning,executing,managingrisk,managingcriticalpathsandcommercializingEnterprise 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 toengage incross 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:

• Leadcomplex 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.

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

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

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

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

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

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

• Establishand monitor program metrics, KPIs, and dashboards to proactivelyidentifyrisks, improve execution, and support data-driven decision-making.

• Coordinatesoftware verification, validation, traceability, documentation, and release readiness activities for regulated medical device software products.

• Ensuredeployment, implementation, and commercialization plansto addressboth customer-hosted (on-premises) and cloud-hosted environments whilemaintainingsecurity, compliance, and quality requirements.

• Leadprocess standardization initiatives across software development teams,identifyopportunities to streamline workflows, reduce cycle times, and improve product quality.

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

• Establishappropriate governancestructures to ensure alignment, accountability, and clear decision-making across stakeholders.

• Maintainaccountability for Design History File (DHF) deliverables, regulatory requirements, and compliance with applicable QMS procedures.

• Capturelessons learned and drive adoption of best practices across programs and project teams.

QUALIFICATIONS:

• Bachelor's degreerequired; 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 knowledgepreferred.

• Lean Six Sigma certification (Green Belt or Black Belt) ordemonstratedexperience 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.

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