Engineer II, Process Engineering

Integra-Lifesciences; Irvine (CA); On-site; USD 71,300 - 97,750; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Life insurance

Disability insurance

401(k) savings plan

Job summary

Integra LifeSciences is seeking a Process Engineer to optimize and sustain manufacturing processes within a value stream using lean and six-sigma tools to improve efficiency and quality.

You will conduct validations (IQ/OQ/PQ/TMV), lead cross-functional teams, analyze SPC data, and drive cost, reliability, and process improvements across the product lifecycle in a GMP-regulated environment.

Qualifications

• Statistical process control tools desired (SPC, Minitab, other software).
• Lean Six Sigma experience desired.
• Demonstrate excellent organizational and English communication skills (oral & written).
• Project management and process improvement experience desired.

Responsibilities

• Perform SPC analysis and trending of process parameters to improve yields and reduce scrap.
• Execute IQ/OQ/PQ/TMV validations and manage ECR/ECOs and equipment/process drawings.
• Lead cross-functional teams and participate in lifecycle management and sustaining engineering changes.
• Monitor KPIs and drive cost, quality, reliability improvements across value streams.
• Develop hands-on training programs for product/process changes.
• Conduct time studies and align BOMs/routers with process from transfer to lifecycle.

Skills

SPC

Lean Six Sigma

English communication

Project management

Process improvement

Education

Bachelor’s degree in engineering

Tools

SAP

CRM platforms

MS Project

Jira

QMS platforms

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.SUMMARYThe 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 RESPONSIBILITIESWork 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 process 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.QUALIFICATIONSBachelor’s degree in engineering or equivalent with 0-2 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 skillsProject management and process improvement experience desiredKnowledge in MS Office skillsTools And Equipment UsedThis 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.Salary Pay Range:$71,300.00 - $97,750.00 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