Senior Manager, Value Stream Leader

Integra LifeSciences; Añasco (PR); On-site; USD 87,000 - 122,000; Full time

Job summary

Integra LifeSciences in United States is seeking a Senior Manager, Value Stream Leader to oversee the end-to-end Tissue Technology production value stream, including design transfers, lifecycle management, and final device shipment.

You will lead safety, quality, regulatory, engineering, and operations, drive Lean/Six Sigma improvements, manage budgets, and ensure on-time delivery while maintaining compliance with FDA QSR, ISO 13485, and other standards.

Qualifications

• Engineering or technical degree with 8+ years leading a team.
• Master’s degree with 5+ years of leadership.
• Strong English communication skills.
• Experience in regulated medical device environments.
• Proficiency with ERP, QA systems, and data analysis tools.

Responsibilities

• Oversee end-to-end Tissue Technology value stream, ensuring safety, quality, and productivity.
• Lead staffing, training, and daily operations across shifts.
• Partner with Quality and Regulatory to ensure FDA/ISO compliance.
• Drive Lean/Six Sigma initiatives and cost control.
• Develop and manage budgets and COGS in the value stream.
• Collaborate with cross-functional teams to meet customer needs.

Skills

English communication

Leadership

Regulatory awareness

MS Office

Statistical analysis

Education

Engineering or Technical degree

Master’s degree

Tools

Oracle

Jira

MS Project

QMS platforms

ERP systems

Job description

Changing lives. Building Careers.

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.

Senior Manager, Value Stream Leader

Responsible for end-to-end performance of a Tissue Technology medical device production value stream platform. Work includes acceptance of design transfers, through lifecycle management to final device shipment. Implement strategies and plans to meet short and long‑term goals to achieve the highest standards of safety, quality, customer service, and productivity. Oversee safety and security, manufacturing, engineering, quality, regulatory, and project management within the value stream, measured by safety, quality, delivery, and cost key performance indicators (KPIs). Ensure production complies with corporate policies, U.S. Food and Drug Administration regulations, ISO 9001, ISO 13485, EU MDR, Canadian Medical Device Regulations (CMDR), and other applicable agencies.

Reporting & Management Scope

Under direct supervision of the Plant Manager.

Supervision Exercised

Position will directly manage operations technicians, operators, managers, supervisors, and process engineers.

Key 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 leads accident, near miss, and incident event notifications.
• Lead, coach, and develop a team of technicians, operators, managers, supervisors, and process engineers.
• Responsible for managing 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. Interview job candidates, complete performance reviews, and justify 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.
• Responsible for the team’s compliance and meeting the quality standards as defined by Integra’s SOPs, GMPs, Global Quality Standards, local and procedures, where applicable. 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, including development of manufacturing process requirements, specifications, Failure Mode Effects Analysis (FMEA), validations, Engineering Change Requests/Orders (ECR/ECO) and Engineering Drawings.
• Ensures investigations/CAPAs/nonconformances identify root cause, are appropriately corrected with sustainable remediations. Leverage data/tools/techniques to identify root causes and implement sustainable corrective actions.
• Ensure training and process documentation requirements are consistently met.
• Partner with supplier quality and procurement to ensure supplier issues and changes are addressed appropriately within the quality management system in a timely manner.
• Coach/mentor lean six-sigma manufacturing initiatives (5S, Kaizen, Value Stream Mapping, Kanban, Standard Work, OEE) to reduce waste and improve flow across the value stream.
• Ensure teams deliver measurable improvements in yield, throughput, and cycle time across the value streams in line with KPI targets.
• Partner with cross‑functional teams to meet customer fulfillment needs as well as lead process optimization, yield improvement, six sigma process excellence and lean projects. Monitor process capability and performance metrics (CoPQ, Cpk, yield, run time, downtime, scrap). Develop process/project improvement and mitigation projects to improve capability and performance.
• Develops, reviews, approves, and is accountable for all financial budgets within the value stream, including headcount, expense, capital, and inventory.
• Ensure value stream cost of goods sold (COGS) results are in line with financial targets by ensuring bill‑of‑materials (BOMS), routers, and process instructions align to costs.
• 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 vendors or customer representatives concerning projects & operational decisions.
• Complete other job-related duties as assigned.

Skills & Competencies

• 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’s 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‑motivation and 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, telephone communication systems), software and systems (ERP systems such as Oracle, CRM platforms, statistical analysis tools, project management software such as MS Project, Jira, QMS platforms).

Physical Requirements

• Sit, listen, speak, and move throughout the building.
• Travel across all company locations as needed.
• Periodically lift and/or move items up to twenty‑five pounds.
• Travel domestically and internationally via car, train, or airplane as required.

Adverse Working Conditions

• Handling hazardous and biohazardous materials such as flammable and corrosive liquids, compressed gases, medical waste. Appropriate safety protocols and personal protective equipment (PPE) are required and provided.

Salary Pay Range

$87,000.00 – $122,000.00 USD.

Our salary ranges are determined by role, level, and location. Individual pay is determined by several factors including job‑related skills, experience, and relevant education or training. In addition to base pay, employees may be eligible for bonus, commission, equity or other variable compensation. Your recruiter can share more about the specific salary range for your preferred location during the hiring process.

Total Rewards (Integra LifeSciences)

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, group legal insurance, and savings plan (401(k)).

EEO Statement

Integra LifeSciences is an equal opportunity employer, and is 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.

Unsolicited Agency Submission

Integra LifeSciences does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre‑existing agreement is in place. A formal written agreement is required before engaging any agency, and it must be executed and authorized by the Vice President, Talent Acquisition. Where agency agreements are in place, introductions (the initial sharing of a candidate’s name, resume, or background) are position‑specific and may only occur within the scope of that approved agreement. Please do not use phone calls or emails.