Process Engineer II - VS Neuro/BioPatch/FP

Integra LifeSciences Corporation; Añasco (PR); On-site; USD 42,000 - 59,000; Full time

Job summary

Integra LifeSciences Corporation in Añasco is seeking a Process Engineer II responsible for optimizing manufacturing processes using lean and six sigma methodologies. This role involves working cross-functionally to address process challenges and ensure compliance with regulatory requirements.

The ideal candidate will have a Bachelor’s degree in engineering, with 2-4 years of experience and proficiency in statistical process control and project management. The position offers a competitive salary and the chance to contribute to innovative healthcare solutions.

Qualifications

• 2-4 years of experience in a relevant engineering role.
• Knowledge of SPC, lean six sigma methodologies.
• Experience in managing multifunctional teams.

Responsibilities

• Optimize manufacturing processes using lean and six sigma tools.
• Conduct engineering studies and process validations.
• Represent value stream in cross-functional teams.

Skills

Statistical process control tools

Lean Six Sigma Experience

Project management

Communication skills in English

Good Technical writing skills

Education

Bachelor’s degree in engineering or equivalent

Tools

ERP systems (e.g., SAP)

Statistical analysis tools

Project management software (e.g., MS Project, Jira)

Job description

## Process Engineer II - VS Neuro/BioPatch/FPApplylocations: US-PR-Anasco-165-Facilitytime type: Full timeposted on: Posted Yesterdayjob requisition id: JR-6091Changing 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 Engineer** II is responsible to understand, optimize, and sustain manufacturing processes within a value stream leveraging lean and six sigma tools and methodologies to improve processing, layout, workflow, assets, assembly methods, and workforce usage to process efficiency. They develop end-to-end process and product understanding and control and address lifecycle management and sustaining engineering changes. They execute of their duties in compliance with corporate policies, U.S. Food and Drug Administration regulations, Good Manufacturing Practices (GMP), ISO 9001, ISO 13485, EU MDR, the Canadian Medical Device Regulations (CMDR), and other applicable regulatory agency.**KEY RESPONSIBILITIES**• Work cross-functionally with EHS, product development, process technology, Centers of Excellence (CoE's), facilities, quality, regulatory, planning, procurement to address process challenges, material changes, and well as lifecycle and sustaining changes.• Represent value stream teams in strategic site and enterprise projects on cross-functional teams addressing quality improvements, lifecycle management efforts, new product introductions, etc.• Execute engineering studies, IQ/OQ/PQ/TMV validations, manufacturing process requirements, specifications, Engineering Change Requests/Orders (ECR/ECO), and Engineering Drawings for equipment and processes.• Conduct statistical process control (as necessary) analysis and trending of existing process parameters, process inputs and outputs, improve manufacturing yields, reduce manufacturing scrap, and error proof manufacturing processes.• Perform timely technical investigations, non-conformance, Failure Mode Effects Analysis (FMEA), and Corrective and Preventive Action (CAPA).• Complete projects to drive process, quality, reliability and cost improvements leveraging advanced technologies, lean six-sigma tools and methodologies.• Conduct time studies, process evaluations, and technical evaluations to align Bills of Materials, work instructions, and routers with processes to ensure cost accuracy from product transfer through product lifecycle.• Monitor performance metrics for value stream(s) and develop improvement actions necessary to attain targeted performance Key Performance Indicators (KPI's).• Develop hands-on product/process/equipment training programs.• Participate in cross-functional process and product project teams including product development, quality assurance, facilities, regulatory, and manufacturing.• Complete other job-related duties as assigned**SKILLS & COMPETENCIES*** Bachelor’s degree in engineering or equivalent with 2-4 years of experience.* Statistical process control tools desired (SPC, Minitab, other software).* Lean Six Sigma Experience Preferred.* Demonstrate excellent organizational and English communication skills (oral & written)* Positive, sound interpersonal, and employee development skills* Project management and process improvement experience desired* Knowledge in MS Office skills**Additional Key Requirements:*** Experience in managing multifunctional teams including EHS, Quality, Process Development, Planning and Materials Engineers* Worked with global teams on enterprise projects to address quality improvements, lifecycle management plans, and NPI.* Executed material change validations.* Minimum of 2 years managing validation cycles (FAT, IQ, OQ, PQ TMV), engineering studies and documentation changes.* Proven experience in process monitoring(SPC) and improvements of KPI’s with the use of Statistical Tools, and Lean Six Sigma Tools.* Performed Technical investigations, NC and CAPA’s* Preferred experience with time studies.* Preferred experience with Design of Experiments (DOE)* Preferred Basic knowledge in automation, programming, sensors, and Vision systems* Basic Project Management skills* Good communication skills in both Spanish and English* Good Technical writing skills**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, fax 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.**DISCLAIMER** The responsibilities and duties outlined above are intended to illustrate the general nature and level of work performed by individuals assigned to this position. They do not represent an exhaustive list of all tasks that may be required. Additional duties may be assigned as appropriate to meet business needs. This job description does not constitute a contract of employment and is subject to change at the discretion of the employer, based on evolving organizational requirements and role expectations.#LI-EM1Salary Pay Range:$42,000.00 - $59,000.00 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.