Process Engineer II - VS Collagen/LYO

INTEGRA CI INC; Añasco (PR); On-site; USD 42,000 - 59,000; Full time

Benefits offered by this job

Medical/dental/vision insurance

Life insurance

Disability insurance

Business accident insurance

Group legal insurance

401(k) plan

Job summary

Integra LifeSciences in the United States invites an engineer to understand, optimize, and sustain manufacturing processes within a value stream using lean and six sigma tools in a regulated environment.

You will lead cross‑functional teams, perform SPC analyses, validate processes, drive cost and quality improvements, and develop hands‑on training for product, process, and equipment to support lifecycle transfers and enterprise projects.

Qualifications

• Bachelor’s degree in engineering or equivalent; 2+ years experience preferred.
• SPC tools (Minitab or similar) experience.
• Lean Six Sigma experience.
• Excellent written and spoken English communication skills.
• Strong interpersonal and employee development abilities.
• Project management and process improvement experience.
• Proficiency in MS Office.

Responsibilities

• Work cross‑functionally with EHS, product development, process technology, CoE, facilities, quality, regulatory, planning, and procurement to address process challenges, material changes, and lifecycle and sustaining changes.
• Represent value stream teams on strategic site and enterprise projects addressing quality improvements, lifecycle management efforts, and new product introductions.
• Execute engineering studies, IQ/OQ/PQ/TMV validations, manufacturing process requirements, specifications, ECR/ECO, and engineering drawings for equipment and processes.
• Conduct SPC analyses and trend process parameters to improve yields, reduce scrap, and error‑proof processes.
• Perform technical investigations, non‑conformance management, FMEA, and CAPA.
• Lead projects to drive process, quality, reliability, and cost improvements using lean six‑sigma tools and methodologies.
• Conduct time studies, process evaluations, and technical evaluations to align BOMs, work instructions, and routers with processes for cost accuracy from product transfer through lifecycle.
• Monitor value‑stream KPIs and develop improvement actions to achieve targets.
• Develop hands‑on product/process/equipment training programs.
• Participate in cross‑functional product and process project teams including product development, quality assurance, facilities, regulatory, and manufacturing.
• Complete other job‑related duties as assigned.

Skills

SPC tools (Minitab)

Lean Six Sigma

English communication

Interpersonal skills

Project management

MS Office

Education

Bachelor’s degree in engineering

Tools

Minitab

Job description

Job Overview

Responsible for understanding, optimizing, and sustaining manufacturing processes within a value stream using lean and six sigma tools to improve processing, layout, workflow, assets, assembly methods, and workforce usage in a regulated environment.

Key Responsibilities

• Work cross‑functionally with EHS, product development, process technology, Centers of Excellence (CoE), facilities, quality, regulatory, planning, and procurement to address process challenges, material changes, and lifecycle and sustaining changes.
• Represent value stream teams on strategic site and enterprise projects addressing quality improvements, lifecycle management efforts, and new product introductions.
• 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 analysis and trend existing process parameters, inputs and outputs; improve manufacturing yields, reduce scrap, and error‑proof processes.
• Perform technical investigations, non‑conformance management, Failure Mode Effects Analysis (FMEA), and Corrective and Preventive Action (CAPA).
• Lead projects to drive process, quality, reliability, and cost improvements using 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, ensuring cost accuracy from product transfer through the lifecycle.
• Monitor value‑stream performance metrics and develop improvement actions to achieve targeted performance KPIs.
• Develop hands‑on product/process/equipment training programs.
• Participate in cross‑functional product and process 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 (SPC, Minitab, or other software).
• Lean Six Sigma experience.
• Excellent organizational and English communication skills (oral & written).
• Positive interpersonal skills and employee development capabilities.
• Project management and process improvement experience.
• Proficiency in MS Office.

Additional Requirements

• Experience managing multi‑functional teams including EHS, quality, process development, planning, and materials engineers.
• Experience working with global teams on enterprise projects addressing quality improvements, lifecycle management, and new product introductions.
• Minimum of 2 years managing validation cycles (FAT, IQ, OQ, PQ, TMV), engineering studies, and documentation changes.
• Proven experience in process monitoring (SPC) and KPI improvement using statistical and Lean Six Sigma tools.
• Experience in technical investigations, non‑conformance, and CAPA.
• Preferred experience with time studies and design of experiments (DOE).
• Basic knowledge of automation, programming, sensors, and vision systems.
• Basic project management skills.
• Good communication skills in Spanish and English.
• Good technical writing skills.

Salary

Pay Range: $42,000 – $59,000 USD. Salary determined by role, level, location, skills and experience. Employees may also be eligible for bonus, commission, equity or other variable compensation.

Benefits

• Medical, dental, and vision coverage.
• Life insurance.
• Short‑term and long‑term disability insurance.
• Business accident insurance.
• Group legal insurance.
• 401(k) savings plan.

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. Employees are eligible for reasonable accommodations in accordance with the ADA.