Senior Manager, Design Quality

Fortive

Senior Manager managing design quality and development excellence throughout the product lifecycle for medical devices. Leading a team to ensure compliance and effective product launches.

Posted 5/1/2026full-timeRemote • 🇺🇸 United StatesSeniorWebsite

About the role

Key responsibilities & impact

Defines and executes an end‑to‑end product lifecycle design quality strategy, ensuring alignment from development through commercialization and ongoing post‑market performance.
Accountable for assuring end‑to‑end design control activities are effectively executed by programs, including traceability from user needs through verification and validation.
Responsible for design risk management and assurance that usability engineering activities are appropriately applied and effective in accordance with applicable standards (e.g., ISO 14971, IEC 62366).
Ensures Design History Files (DHF) demonstrate completeness, accuracy, and readiness to support high‑quality product launches and inspections.
Accountable for assuring the effectiveness and adequacy of design verification and validation (V&V) activities by reviewing and approving strategies, protocols, and reports.
Confirms statistical rationale, sample sizes, and coverage of design and user requirements are appropriate to demonstrate product performance and intended use.
Assures objective evidence is sufficient to verify all design risk controls and support a high‑quality, compliant product launch.
Provides oversight and challenge to program teams to ensure V&V findings, design evaluations, root cause analyses, and regression testing results are appropriately addressed.
Owns and drives product quality improvement projects to address post‑market feedback, field issues, and emerging risk signals.
Partners with Customer Quality, Manufacturing Quality, Supplier Quality, and R&D to translate field data, complaints, and reliability insights into prioritized design improvements.
Leads root cause analysis and cross‑functional countermeasure implementation to prevent recurrence and improve product performance across the lifecycle.
Partners with Regulatory and Clinical teams to support regulatory submissions and inspections.
Provides subject‑matter expertise for design controls, V&V, and risk management during audits.
Promotes advanced quality engineering practices and a culture of quality excellence and continuous improvement.
Directly leads, coaches, and develops a team of design quality engineering professionals.
Sets clear performance expectations, provides regular feedback, and supports technical skill development.
Fosters a culture of accountability, technical rigor, and continuous improvement.

Requirements

What you’ll need

Bachelor’s in Engineering, Science, or related field; advanced degree (MS, MBA) preferred.
12+ years in medical device quality/engineering across the product lifecycle (design controls, supplier quality, manufacturing quality, customer quality), with 7+ years managing people and managers.
Direct experience preparing for/hosting FDA, Notified Body, and other health authority inspections; strong understanding of regulatory submissions and technical documentation expectations.
Equivalent combination of education and experience will be considered.

Benefits

Comp & perks

Travel up to 25–30%, domestic and international.
Work may occur in office, lab, manufacturing, and supplier environments; ability to use appropriate PPE and comply with site‑specific EHS requirements.
Typical office activities include extended periods of sitting/standing, keyboard use, and frequent communication.
Lifting up to 25 lbs occasionally; occasional walking/standing on manufacturing floors.
Schedule may periodically require coverage across global time zones.

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

design controldesign verificationdesign validationrisk managementusability engineeringroot cause analysisstatistical analysisquality improvementproduct lifecycle managementtechnical documentation

Soft Skills

leadershipcoachingcommunicationaccountabilitycollaborationproblem-solvingperformance managementcontinuous improvementoversightfeedback