Sr. Manager, Value Stream

About the role

Joining us is a chance to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, our colleagues are challenging what’s possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care.

Responsibilities

• Ensures the safety of colleagues through effective and continuously improving environmental, health, and safety program engagement.
• Ensure all team members receive training, and are knowledgeable and compliant regarding safety procedures, policies, permits, practices, PPE, proper housekeeping, and awareness.
• Initiates and lead accidents, near miss, and incident event notifications.
• Lead, coach, and develop a team of supervisors and managers.
• Manage staffing, training, and daily maintenance operations across shifts up to 7 days a week, including attendance, overtime, operational issues, talent management, performance management, development planning, and reporting of results.
• Interviews job candidates, completes performance reviews, and justifies promotions or disciplinary actions (as appropriate).
• Serve as a member of the site leadership team participating in strategic and tactical planning & execution to ensure site objectives are met.
• Ensure alignment of value stream objectives with overall site objectives.
• Foster a culture of colleague engagement through positive leadership, recognition, accountability, feedback, continuous improvement, and engagement activities.
• Ensure the production of medical products in compliance with corporate policies, U.S. Food and Drug Administration regulations, ISO 9001, ISO 13485, EU MDR, the Canadian Medical Device Regulations (CMDR), and other applicable regulatory agencies.
• Partner with Quality Assurance and Regulatory Affairs to ensure full compliance with applicable standards (FDA QSR, GMP, ISO 13485, etc).
• Initiate, develop, and implement engineering studies and IQ/OQ/PQ/TMV validations for equipment and processes to meet the demands of new product introductions and current manufacturing operations.
• Coordinate specific efforts as required by the project team.
• Develop process/project improvement and mitigation projects to improve capability and performance.
• Develops, reviews, approves, and accountable for all financial budgets within the value stream, including headcount, expense, capital, and inventory.
• Maintain process capability and performance metrics (CoPQ, Cpk, yield, run time, downtime, scrap).
• Work cross-functionally and collaboratively to solve operational issues.
• Interact with senior management on matters concerning several job areas, departments, and/or customers to accept new concepts, practices, and approaches as well as with senior level vendor or customer representatives concerning projects & operational decisions.

Requirements

Engineering or Technical degree with 8+ years of experience leading a team (direct reports or projects) or equivalent education and years of management experience OR Master degree with 5+ years of experience leading a team (direct reports or projects) or equivalent education and years of management experience.

Demonstrate excellent organizational and English communication skills (oral & written).

Financial acumen relating to operations profit & loss (P&L) items.

Proficiency in MS Office Suite and statistical analysis software.

Experience in regulated environment; medical device or pharma preferred.

Familiarity with health, safety, and environmental regulations related to manufacturing.

Self-motivated team player with ability to work independently and collaboratively across all levels of the organization.

Tools And Equipment Used

• General office equipment: Computers, printers, copiers, fax machines, and telephone communication systems.
• Software and systems: ERP systems (e.g., Oracle), CRM platforms, statistical analysis tools, project management software (e.g., MS Project, Jira), QMS platforms.

Qualifications

Engineering or Technical degree with 8+ years of experience leading a team (direct reports or projects) or equivalent education and years of management experience OR Master degree with 5+ years of experience leading a team (direct reports or projects) or equivalent education and years of management experience.

Demonstrate excellent organizational and English communication skills (oral & written).

Financial acumen relating to operations profit & loss (P&L) items.

Proficiency in MS Office Suite and statistical analysis software.

Experience in regulated environment; medical device or pharma preferred.

Familiarity with health, safety, and environmental regulations related to manufacturing.

Self-motivated team player with ability to work independently and collaboratively across all levels of the organization.

Tools And Equipment Used

• General office equipment: Computers, printers, copiers, fax machines, and telephone communication systems.
• Software and systems: ERP systems (e.g., Oracle), CRM platforms, statistical analysis tools, project management software (e.g., MS Project, Jira), QMS platforms.

Skills

• Engineering or Technical degree with 8+ years of experience leading a team (direct reports or projects) or equivalent education and years of management experience OR Master degree with 5+ years of experience leading a team (direct reports or projects) or equivalent education and years of management experience.
• Demonstrate excellent organizational and English communication skills (oral & written).
• Financial acumen relating to operations profit & loss (P&L) items.
• Proficiency in MS Office Suite and statistical analysis software.
• Experience in regulated environment; medical device or pharma preferred.
• Familiarity with health, safety, and environmental regulations related to manufacturing.
• Self-motivated team player with ability to work independently and collaboratively across all levels of the organization.
• Tools And Equipment Used
  • General office equipment: Computers, printers, copiers, fax machines, and telephone communication systems.
  • Software and systems: ERP systems (e.g., Oracle), CRM platforms, statistical analysis tools, project management software (e.g., MS Project, Jira), QMS platforms.

Benefits

Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance, and savings plan (401(k)).

Pay

Pay Range: $109,000.00 - $150,000.00 USD