Senior Manager, Design Quality
Location
United States
Posted
29 days ago
Salary
0
Seniority
Senior
Job Description
Senior Manager, Design Quality
Fortive
• 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.
Job Requirements
- 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
- 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.
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