Manager, Process Engineering – Collagen/Lyo Value Stream

Integra-Lifesciences; Añasco (PR); On-site; USD 73,000 - 102,000; Full time

Job summary

Integra LifeSciences seeks a Process Engineering Manager to lead the site value stream's equipment and processes. You will drive end-to-end process understanding, lifecycle management, and continuous improvement to ensure quality, productivity, and yield while complying with GMP and regulatory standards.

You will supervise engineers and technicians, develop talent, and manage budgets, with accountability for COI metrics, risk mitigation, and cross-functional collaboration to meet customer

Qualifications

• Engineering or technical degree with leadership experience.
• Proven ability to manage multidisciplinary teams and projects.
• Experience in regulated manufacturing environments (medical device/pharma) and GMP/Quality systems.

Responsibilities

• Lead safety and EH&S program engagement; ensure training and compliance.
• Direct production line support for new products, transfers, and validations.
• Oversee engineering studies, ECOs, CAPA, FMEA, and change control processes.

Skills

Team leadership

English communication

Project management

Statistical analysis

MS Office

ERP systems (e.g., SAP)

Education

Engineering or Technical degree

Master's degree

Tools

SAP

MS Project

Jira

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.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 RECEIVEDUnder direct supervision of the Value Stream ManagerSUPERVISION EXERCISEDPosition Will directly manage a team of process engineers and technicians.KEY RESPONSIBILITIESEnsure 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 & COMPETENCIESEngineering 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 USEDThis 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 REQUIREMENTSThe 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 SalaryOur 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 LifeSciencesIntegra 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 VeteransIntegra 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] Agency SubmissionIntegra 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, no phone calls or emails.Integra - Employer Branding from Integra LifeSciences on Vimeo