Senior Manager, Value Stream Leader

INTEGRA LIFESCIENCES PRODUCTION CORPORATION; Añasco (PR); On-site; USD 87,000 - 122,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) plan

Disability insurance

Job summary

Integra LifeSciences is seeking a Senior Manager, Value Stream Leader to own the end-to-end performance of a Tissue Technology medical device production value stream. You will ensure safety, quality, and productivity while coordinating design transfers, lifecycle management, and final device shipment.

You will lead a cross-functional team, drive lean Six-Sigma projects, manage budgets, and partner with Quality Assurance and Regulatory Affairs to meet FDA QSR, GMP, and ISO standards.

Qualifications

• Engineering or technical degree required, with 8+ years leading a team or equivalent management experience; or master’s degree with 5+ years of leadership experience.
• Excellent organizational and written and oral English communication skills.
• Financial acumen related to operations profit & loss management.
• Proficiency in MS Office Suite and statistical analysis software.
• Experience in a regulated environment (medical device or pharmaceutical preferred).
• Familiarity with health, safety, and environmental regulations.

Responsibilities

• Ensure safety of colleagues through an effective EHS program.
• Lead, coach, and develop a team of technicians, operators, managers, supervisors, and process engineers.
• Manage staffing, training, and daily maintenance operations across shifts and reporting of results.
• Conduct performance reviews and justify promotions or disciplinary actions.
• Collaborate with Quality Assurance and Regulatory Affairs to meet FDA QSR, GMP, ISO 13485 standards.
• Lead process optimization and lean projects to improve yield, throughput, and cycle time.

Skills

Team leadership

English communication

Financial acumen

MS Office

Statistical analysis

Education

Engineering or Technical degree

Master’s degree

Tools

ERP (Oracle)

CRM platforms

MS Project

Jira

Statistical analysis software

Job description

Senior Manager, Value Stream Leader is responsible for end‑to‑end performance of a Tissue Technology medical device production value stream platform. The role includes acceptance of design transfers, lifecycle management, and final device shipment, ensuring safety, quality, customer service, and productivity.

Key Responsibilities

• Ensure the safety of colleagues through an effective and continuously improving environmental, health, and safety program.
• Provide training and maintain team knowledge of safety procedures, policies, permits, practices, PPE, housekeeping, and awareness.
• Initiate and lead accident, near‑miss, and incident event notifications.
• Lead, coach, and develop a team of technicians, operators, managers, supervisors, and process engineers.
• Manage staffing, training, daily maintenance operations across shifts, attendance, overtime, operational issues, talent management, performance management, development planning, and reporting of results.
• Conduct interviews, complete performance reviews, and justify promotions or disciplinary actions.
• Serve on the site leadership team for strategic and tactical planning & execution to meet site objectives.
• Align value stream objectives with overall site objectives and foster a culture of engagement through recognition, accountability, feedback, continuous improvement, and participation.
• Ensure compliance with quality standards defined by SOPs, GMPs, global quality standards, and local procedures.
• Partner with Quality Assurance and Regulatory Affairs to meet FDA QSR, GMP, ISO 13485, and other applicable standards.
• Initiate, develop, and implement engineering studies and IQ/OQ/PQ/TMV validations for equipment and processes.
• Coordinate specific efforts for development of manufacturing process requirements, specifications, FMEA, validations, ECR/ECO, and engineering drawings.
• Investigate CAPAs, nonconformances, and root‑cause analyses, implementing sustainable corrective actions.
• Maintain training and process documentation requirements.
• Collaborate with supplier quality and procurement to address supplier issues and changes within the quality management system.
• Coach and mentor lean Six‑Sigma initiatives (5S, Kaizen, VSM, Kanban, Standard Work, OEE) to reduce waste and improve flow.
• Deliver measurable improvements in yield, throughput, and cycle time in line with KPI targets.
• Lead process optimization, yield improvement, Six‑Sigma process excellence, and lean projects in partnership with cross‑functional teams.
• Monitor process capability and performance metrics (CoPQ, Cpk, yield, run time, downtime, scrap).
• Develop and manage all financial budgets within the value stream, including headcount, expenses, capital, and inventory.
• Ensure cost of goods sold results align with financial targets.
• Solve operational issues collaboratively and interact with senior management on cross‑departmental projects.
• Complete other job‑related duties as assigned.

Qualifications & Competencies

• Engineering or Technical degree with 8+ years of experience leading a team or equivalent management experience; or master’s degree with 5+ years of leadership experience.
• Excellent organizational and written and oral English communication skills.
• Financial acumen related to operations profit & loss management.
• Proficiency in MS Office Suite and statistical analysis software.
• Experience in a regulated environment (medical device or pharmaceutical preferred).
• Familiarity with health, safety, and environmental regulations.
• Self‑motivated team player capable of working independently and collaboratively at all levels.

Tools & Equipment Used

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

Physical Requirements

Employment requires sitting, talking, and moving throughout various areas of the building, travelling across company locations, periodically lifting or moving items up to 25 pounds, and travelling domestically and internationally by car, train, or airplane as required.

Salary & Benefits

Salary Pay Range: $87,000 – $122,000 USD. In addition to base pay, compensation may include bonus, commission, equity, or other variable components. Employees are eligible for medical, dental, vision, life insurance, short‑ and long‑term disability, business accident insurance, group legal insurance, and a 401(k) savings plan.

EEO Statement

Integra LifeSciences is an equal opportunity employer, committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran status. This site is governed solely by applicable U.S. laws and governmental regulations. For more information on your rights, please see the following notices: EEO Is the Law | EOE including Disability/Protected Veterans. Integra LifeSciences is committed to provide qualified applicants and employees who are disabled veterans or individuals with disabilities with needed reasonable accommodations in accordance with the ADA.