Process Engineer II

Integra LifeSciences; Plainsboro Township (NJ); On-site; USD 71,300 - 97,750; Full time

Benefits offered by this job

Medical, dental, and vision insurance

401(k) savings plan

Life and disability insurance

Job summary

Integra LifeSciences is seeking a Process Engineer in Plainsboro Township, NJ, to optimize and sustain manufacturing processes. The role involves cross-functional collaboration to enhance workflow and efficiency while ensuring compliance with FDA regulations and other industry standards.

Qualified candidates should possess a Bachelor’s degree in engineering, 2-6 years of relevant experience, and knowledge of lean six sigma methodologies. A competitive salary range of $71,300 - $97,750 is offered along with various employee benefits.

Qualifications

• 2-6 years of experience in a relevant field.
• Experience with statistical process control and lean methodologies.
• Validation and requalification experience preferred.

Responsibilities

• Optimize and sustain manufacturing processes using lean and six sigma tools.
• Work cross-functionally with multiple teams to address challenges.
• Lead engineering studies and validations to improve processes.
• Conduct process control analysis and ensure compliance with regulations.

Skills

Statistical process control tools (SPC, Minitab)

Lean Six Sigma

Organizational skills

Communication skills (English)

Project management

Education

Bachelor’s degree in engineering

Tools

ERP systems (e.g., SAP)

MS Project

Jira

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 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. This position will support the Skin Value Stream.

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.
• Lead & 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.
• Respond to immediate escalations from manufacturing floor and elevate to leadership, as needed.
• Complete other job‑related duties as assigned.

Skills & Competencies

• Bachelor’s degree in engineering or equivalent with 2-6 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.
• Validation and requalification experience desired. Cleaning validation experience is a plus.
• Knowledge in MS Office 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

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.

• 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.

Adverse Working Conditions

The conditions listed below represent environmental factors which the employee may be exposed to while performing the essential duties of this position. These reflect a general plant or service environment.

• Flammable and corrosive liquids.
• Compressed gases.
• Sharps.
• Medical waste.

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.

Salary Pay Range

$71,300.00 - $97,750.00 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)).

Equal Opportunity Employer and EEO

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.

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].