Manager, Process Engineering – Collagen/Lyo Value Stream

Integra LifeSciences; Añasco (PR); Presencial; USD 73 000 - 102 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Medical insurance

Dental insurance

Vision insurance

Life insurance

Disability insurance

401(k) plan

Resumo da oferta

Integra LifeSciences is seeking a Process Engineering Manager to lead the site value stream’s equipment and processes. This role drives end-to-end process understanding, lifecycle management, and sustainability through strong engineering practices in support of supply chain integrity.

The manager oversees a team of engineers and technicians, ensuring safety, quality, and productivity while adhering to GMP, ISO 9001, ISO 13485, and other regulatory standards.

Qualificações

• Engineering or technical degree with leadership experience.
• Experience in regulated environments such as medical devices or pharma.
• Strong English communication and organizational skills.

Responsabilidades

• Ensure safety via environmental, health, and safety program engagement.
• Lead production-line support including new products and transfers.
• Develop engineers and technicians; manage attendance and performance.
• Oversee ECOs, CAPAs, NCs, and validations (IQ/OQ/PQ).
• Plan and execute projects ensuring device safety, quality, and reliability.
• Investigate issues and provide practical manufacturing solutions under regs.
• Collaborate with cross-functional teams to meet customer needs and lean goals.
• Monitor cost of goods, BOMs, routers, and process instructions against budgets.
• Handle other duties as assigned.

Conhecimentos

Team leadership

Engineering degree

English communication

Financial acumen

MS Office

SAP

QMS

Regulated environment

Formação académica

Engineering or Technical degree

Master's degree

Ferramentas

SAP

CRM platforms

MS Project

Jira

Descrição da oferta de emprego

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.

The Process Engineering Manager is responsible for the technical and leadership of the site value stream's equipment and processes. They are responsible for end-to-end process and product understanding and control, managing lifecycle management and sustaining engineering changes, and driving improvements in quality, productivity, and yield. They are responsible for multidisciplinary project definition from project hand off, including validation/commissioning, with the goal of optimizing asset lite cycle management and sustainability by using good engineering practices in support of supply chain integrity. They ensure the planning and execution of their duties in compliance with corporate policies, U.S. Food and Drug Administration regulations, Good Manufacturing practices (GMP), ISO 9001, ISO 13485, EU MOR, the Canadian Medical Device Regulations (CMDR), and ofher applicable regulatory agencies.

REPORTING & MANAGEMENT SCOPE SUPERVISION RECEIVED

Under direct supervision of the Value Stream Manager

SUPERVISION EXERCISED

Position Will directly manage a team of process engineers and technicians.

Key Responsibilities

• Ensure 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 investigations.
• Lead team supporting production line operations including new products, and process transfers, equipment qualifications, process validations, process efficiency improvements, and quality and supply issues resolutions.
• Lead and develop a team of engineers and technicians staffing, training, attendance. overtime, operational issues, talent management, performance management, development planning and reporting of results.
• Oversee team develop and implement engineering studies as necessary, specifications and drawings, engineering change orders (ECO), Non-conformances (NC's), Corrective and Preventative Actions (CAPA), Failure Mode Effects Analysis (FMEA), validations (IQ, OQ, PQ, PV, TMV, etc).
• Ensure project planning and execution projects the identity, quality, durability, reliability, safety, and effectiveness of medical devices and, thereby, projects patient safety.
• Performs timely technical investigations and provides practical manufacturing solutions, under appropriate regulatory guidelines for a medical device manufacturer. Ensure team conducts timely and effective non-conformances, investigations, and Corrective and Preventive Action(s) (CAPA).
• Partner with the 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 end performance metrics (CoPQ, Cpk, yield, run time, downtime, scrap). Develop improvement and mitigation projects to improve capability and performance.
• 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. Accountable for all department financial budgets (headcount, expense. capital, inventory).
• Complete other job-related duties as assigned.

Skills & Competencies

• Engineering or Technical degree with 5+ years of experience leading a team (direct reports or projects) or equivalent education and years of management experience or master's degree with 3+ years of experience leading a team (direct or projects) or equivalent education and years of management experience.
• Demonstrate excellent organizational and English communication skills (oral & written).
• Financial acumen relating to investment opportunities, continuous improvement P&L impacts, etc.
• 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.
• Experience in regulated environment; medical device or pharma preferred.
• Self-motivated team player with ability to work independently and collaboratively across all levels of the organization.

TOOLS AND EQUIPMENT USED

This role requires regular use of tools and equipment relevant to the work environment. Examples include:

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

Physical Requirements

The physical requirements listed below represent the motor and physical abilities necessary to successfully perform the essential duties of this position. In accordance with the Americans with Disabilities Act (ADA), reasonable accommodations may be made to enable individuals with disabilities to perform these duties. While performing the responsibilities of this role, the employee is expected to:

• Sit, listen, speak, and move throughout various areas of 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 by the role.

Salary Pay Range: $73,000.00 - $102,000.00 USD Salary

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.

Additional Description for Pay Transparency:

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)).

Subject to the terms of their respective policies and date of hire, Employees are eligible for the following Total Rewards | Integra LifeSciences

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. If you'd like more information on your rights under the law, 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. If you have difficulty using our online system due to a disability and need an accommodation, please email us at [e-mail].