Senior Process Engineer I - VS Collagen/LYO

integralife; Añasco (PR); On-site; USD 51,000 - 71,000; Full time

Job summary

Integra LifeSciences is seeking a Sr. Process Engineer to understand, optimize, and sustain manufacturing processes across value streams, using lean and six sigma methodologies to improve efficiency.

You will ensure GMP, ISO 9001/13485, EU MDR, CMDR compliance and manage lifecycle changes from product transfer through lifecycle, leading cross-functional teams and driving improvements with strong project management skills.

Qualifications

• Bachelor's degree in engineering or equivalent; 5+ years of experience; master's with 3+ years is acceptable.
• Experience with SPC tools (Minitab or similar) required.
• Lean Six Sigma experience is required.
• Strong English communication skills, both written and verbal.
• PMP desired; project management experience preferred.
• Knowledge of ERP/MRP and MS Office.

Responsibilities

• Develop cross-functional networks with EHS, product development, process technology, CoE's, facilities, quality, regulatory, planning, procurement to address process challenges and lifecycle changes.
• Represent value stream teams in strategic site and enterprise projects on cross functional teams addressing quality improvements and lifecycle management.
• Initiate, develop and implement engineering studies, IQ/OQ/PQ/TMV validations, manufacturing process requirements, specs, ECR/ECO, and engineering drawings for equipment and processes.
• Leverage statistical process control to analyze and trend process parameters, improve yields, reduce scrap, and error-proof manufacturing processes.
• Perform timely technical investigations, NC and CAPA.
• Identify, financially justify, and lead projects to drive process, quality, reliability and cost improvements using lean six-sigma tools.
• Ensure value stream BOMS, routers, and work instructions align with process and cost accuracy.
• Complete process improvements actions to attain KPI targets.
• Develop hands-on product/process/equipment training programs.
• Lead cross-functional process and product project teams including product development, quality assurance, facilities, regulatory, and manufacturing.
• Complete other job-related duties as assigned.

Skills

SPC / Minitab / statistical tools

Lean Six Sigma

English communication

Project management

Engineering optimization

Education

Bachelor's degree in engineering or equivalent

Master's degree with 3+ years experience

Tools

SAP ERP

MS Project

Jira

CRM platforms

QMS software

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 Sr. Process Engineer is responsible for understanding, optimizing, and sustaining 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 are responsible for end-to-end process and product understanding and control and manage managing lifecycles sustaining engineering changes. They plan and 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.

REPORTING & MANAGEMENT SCOPE

SUPERVISION RECEIVED: Under direct supervision of the Value Stream or Process Engineering Manager

KEY RESPONSIBILITIES

• Develop a cross-functional network with Environmental, Health, & Safety (EHS), product development, process technology, Centers of Excellence (CoE's), facilities, quality, regulatory, planning, procurement to address process challenges, rial 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.

• Initiate, develop and implement engineering studies, IQ/OQ/PQ/TMV validations, manufacturing process requirements, specifications, Engineering Change Requests/Orders (ECR/ECO), and Engineering Drawings for equipment and processes.

• Leverage statistical process control (as necessary), analyze and trend 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).

• Identify, financially justify, and lead projects to drive process, quality, reliability and cost improvements leveraging advanced technologies, lean six-sigma tools and methodologies.

• Ensure value stream(s) BOMS, routers, and work instructions to align with process and ensure cost accuracy from product transfer through product lifecycle.

• Complete process improvements actions to ensure performance metrics attain targeted performance Key Performance Indicators (KPI's).

• Develop hands-on product/process/equipment training programs.

• Lead 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

• A bachelor’s degree in engineering or equivalent with 5+ years of experience; master’s degree with 3+ years of experience.

• Experience with statistical process control tools required (SPC, Minitab, other software) required.

• Lean Six Sigma Experience Required

• Demonstrate excellent organizational and English communication skills (oral & written) • Sound interpersonal, and employee development skills

• Project management and process improvement experience, PMP desired

• Knowledge in enterprise resource planning, material resource planning, and 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 4 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

• 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

• 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

$51,000.00 - $71,000.00 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].