Process Engineer II - VS Collagen/LYO

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

Job summary

Integra LifeSciences in Puerto Rico is seeking a Process Engineer to understand, optimize, and sustain manufacturing processes using lean and six sigma. You will develop end-to-end process understanding, drive capacity, layouts, and workflow improvements while ensuring compliance with GMP, ISO 9001/13485, EU MDR, and other regulations.

You will collaborate with EHS, product development, quality, and operations to execute validations, monitor KPI improvements, and lead cost and quality

Qualifications

• 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 Desired.
• 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

Responsibilities

• Collaborate cross-functionally to address process challenges and changes.
• Represent value stream teams in site and enterprise projects.
• Execute engineering studies, IQ/OQ/PQ/TMV validations, manufacturing requirements and ECR/ECOs.
• Conduct SPC analysis to improve yields and reduce scrap.
• Perform technical investigations, NC and CAPA.
• Complete projects to drive process, quality, reliability and cost improvements using lean six-sigma tools.
• Conduct time studies and align Bills of Materials, work instructions, and routers.
• Monitor KPIs and develop improvement actions to meet targets.
• Develop hands-on training programs for product/process/equipment.
• Participate in cross-functional process and product project teams.
• Complete other job-related duties as assigned.

Skills

English communication

Organizational skills

Project management

Interpersonal skills

Spanish language

Education

Bachelor’s degree in engineering or equivalent

Tools

MS Office

SPC / Minitab

Lean Six Sigma

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 Engineer 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 agencies.

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 Desired.
• 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 Hey Requirements

• Experience in managing multi‑functional 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

Salary Pay Range:

$42,000.00 - $59,000.00 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.

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.

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