Manager, Validation & Verification

Regulatory Jobs; Boston (MA); Hybrid; USD 104,000 - 176,000; Full time

Job summary

Haemonetics seeks a Manager of Validation & Verification to lead V&V activities for medical device and software products. You will provide technical direction, oversight, and coaching to a cross-functional team in Boston.

You will establish strategies, schedules, and test evidence aligned with design controls and regulatory standards, while collaborating with Systems, Software, Hardware, Quality, and Regulatory partners.

Qualifications

• Bachelor's degree in engineering, computer science, biomedical engineering, or related technical discipline required.
• Minimum of 8 years of relevant experience in medical device/software/system verification, validation, quality engineering, or related regulated product development.
• Prior people leadership, project leadership, or technical team leadership experience required.
• Experience with FDA Quality System Regulation, ISO 13485, IEC 62304, ISO 14971, design controls, risk management, and requirements management preferred.
• Experience with requirements and test management tools such as Polarion, DOORS, Jama or similar platforms preferred.

Responsibilities

• Develop team capability through coaching, performance management, workload balancing, hiring support, training, and professional development planning.
• Lead and manage the Validation & Verification team responsible for planning, developing, executing, and documenting verification and validation activities for medical device and software-enabled products.
• Establish and maintain V&V strategies, schedules, resource plans, and deliverables aligned with product development milestones, regulatory expectations, and business priorities.
• Provide technical and compliance oversight for test plans, requirements traceability, protocols, test methods, test reports, defect investigations, and objective evidence supporting design verification and validation.
• Drive consistent application of design controls, risk management, test method validation, software validation, and quality system procedures across assigned programs.
• Partner with cross-functional leaders to identify verification and validation risks, remove execution barriers, support issue resolution, and communicate impacts to project scope, schedule, quality, and compliance.
• Review and approve verification and validation documentation, including test protocols, reports, traceability matrices, deviations, nonconformances, and change impact assessments.
• Promote continuous improvement in V&V processes, tools, templates, metrics, automation practices, and test management approaches to improve quality, efficiency, and predictability.
• Prepare and present clear status updates, technical summaries, resource needs, risks, and recommendations to functional leadership and program stakeholders.
• Ensure team deliverables support regulatory submissions, audit readiness, design history files,and product release decisions as applicable.

Skills

People leadership

Cross-functional collaboration

Project leadership

Regulatory knowledge

Communication

Education

Bachelor's degree in Engineering, Computer Science, Biomedical Engineering, or related technical discipline

Tools

Polarion

DOORS

Jama

Job description

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 Manager, Validation & Verification is responsible for leading validation and verification activities for medical device, software, and system-level product development programs. This role provides people leadership, technical direction, and execution oversight to ensure test strategies, protocols, methods, and objective evidence meet product requirements, design control expectations, quality system procedures, and applicable regulatory standards. The manager partners cross-functionally with Systems Engineering, Software, Hardware, Quality, Regulatory, Project Management, and Operations to plan and execute verification and validation work, resolve technical and compliance risks, improve test processes, and develop a high-performing team. Please note that this role requires that you are Hybrid 3 days per week in our Boston office located at 125 Summer Street.

Essential Duties:

• Develop team capability through coaching, performance management, workload balancing, hiring support, training, and professional development planning.
• Lead and manage the Validation & Verification team responsible for planning, developing, executing, and documenting verification and validation activities for medical device and software-enabled products.
• Establish and maintain V&V strategies, schedules, resource plans, and deliverables aligned with product development milestones, regulatory expectations, and business priorities.
• Provide technical and compliance oversight for test plans, requirements traceability, protocols, test methods, test reports, defect investigations, and objective evidence supporting design verification and validation.
• Drive consistent application of design controls, risk management, test method validation, software validation, and quality system procedures across assigned programs.
• Partner with cross-functional leaders to identify verification and validation risks, remove execution barriers, support issue resolution, and communicate impacts to project scope, schedule, quality, and compliance.
• Review and approve verification and validation documentation, including test protocols, reports, traceability matrices, deviations, nonconformances, and change impact assessments.
• Promote continuous improvement in V&V processes, tools, templates, metrics, automation practices, and test management approaches to improve quality, efficiency, and predictability.
• Prepare and present clear status updates, technical summaries, resource needs, risks, and recommendations to functional leadership and program stakeholders.
• Ensure team deliverables support regulatory submissions, audit readiness, design history files,and product release decisions as applicable.
• Other duties as assigned

Supervises individual contributors and technical leads, contractors, or external test resources. Responsibilities include hiring support, onboarding, goal setting, coaching, performance feedback, development planning, workload prioritization, and ensuring team compliance with applicable procedures and quality expectations.

QUALIFUCATIONS:

• Bachelors of Arts or Science Engineering, Computer Science, Biomedical Engineering, or related technical discipline, required

• Minimum of 8 years of relevant experience in medical device, software, system verification, validation, quality engineering, systems engineering, or related regulated product development; or equivalent relevant experience.
• Prior people leadership, project leadership, or technical team leadership experience required.
• Experience working within FDA Quality System Regulation, ISO 13485, IEC 62304, ISO 14971, design controls, risk management, requirements management, test method validation, and verification and validation documentation is preferred.
• Experience with requirements and test management tools such as Polarion, DOORS, Jama, or similar platforms is preferred.
• Experience leading cross-functional teams, managing priorities across multiple projects, presenting to leadership, and improving engineering processes is required.

Training/Certifications:

Preferred:

• Training or certification in medical device quality systems, software validation, risk management, Agile development and test, project management, or related engineering leadership disciplines.
• People leadership, coaching, performance management, and team development
• Verification and validation strategy, planning, execution, and documentation
• Design controls, requirements traceability, risk management, and quality system compliance
• Medical device and software lifecycle knowledge, including regulated product development practices
• Cross-functional collaboration, stakeholder management, and executive communication
• Problem solving, decision making, prioritization, and risk-based planning
• Test management, requirements management, defect management, and engineering change control tools
• Continuous improvement, process standardization, metrics, and operational excellence

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, 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 [e-mail].

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