Senior Manager, Value Stream Leader

About the role

The Senior Manager, Value Stream Leader is accountable for the end‑to‑end performance of a Tissue Technology medical‑device production value stream. You will oversee design transfers, lifecycle management and final device shipment while ensuring the highest standards of safety, quality, delivery and cost.

Key responsibilities

• Lead and develop a multidisciplinary team of technicians, operators, managers, supervisors and process engineers across up to seven shifts per week.
• Ensure a robust environmental, health and safety program, providing training, incident reporting and continuous improvement.
• Manage staffing, attendance, overtime, talent development, performance reviews and disciplinary actions.
• Participate in site leadership for strategic and tactical planning, aligning value‑stream goals with overall site objectives.
• Maintain compliance with corporate policies, FDA regulations, ISO 9001, ISO 13485, EU MDR, CMDR and GMP requirements.
• Drive productivity, cost‑control and delivery performance through KPI monitoring and process optimisation.

Required profile

• Proven experience leading manufacturing or value‑stream operations in the medical‑device sector.
• Strong knowledge of regulatory frameworks (FDA, ISO, EU MDR, CMDR) and GMP principles.
• Demonstrated ability to manage multi‑shift teams and complex projects.
• Excellent leadership, communication and problem‑solving skills.

Required skills

• FDA regulatory compliance
• ISO 13485 and ISO 9001 standards
• EU Medical Device Regulation (MDR)
• Canadian Medical Device Regulations (CMDR)
• Good Manufacturing Practices (GMP)
• Process engineering and value‑stream management