Manager, Validation & Verification (Hybrid, Boston)

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.

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.

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 filesand 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:

The base pay actually offered to the successful candidate will take into account without limitation the candidates 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 Companys 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- Monday through Friday 7:30 a.m. 5 p.m. ET or email .

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