Process Engineer II

integralife; Plainsboro Township (NJ); On-site; USD 71,000 - 98,000; Full time

Job summary

Integra LifeSciences in Plainsboro, NJ is seeking a Process Engineer to optimize and sustain manufacturing processes within a value stream using lean and six sigma tools. You will ensure compliance with GMP, ISO standards, and regulatory requirements while supporting the Skin Value Stream from development through transfer and lifecycle management.

The role partners across EHS, product development, facilities, quality, regulatory, and planning to improve yield, reduce scrap, and implement CAPA

Qualifications

• Bachelor’s degree in engineering or equivalent; 2–6 years of experience.
• Experience with SPC tools (Minitab, SPC) desirable.
• Lean Six Sigma experience preferred.
• Excellent organizational and English communication skills.
• Strong interpersonal and employee development abilities.
• Project management and process improvement experience preferred.
• Validation and requalification experience; cleaning validation a plus.
• Proficient in MS Office.

Responsibilities

• Collaborate with cross-functional teams to address process challenges.
• Represent value streams in site and enterprise projects.
• Lead engineering studies and validations (IQ/OQ/PQ/TMV).
• Perform SPC analysis to improve yields and reduce scrap.
• Investigate non-conformances and CAPA.
• Complete projects for process, quality, reliability improvements.
• Align BOMs, work instructions, routers with process.
• Monitor KPI performance and drive improvements.
• Develop hands-on training programs.
• Participate in cross-functional project teams.
• Respond to escalations from manufacturing floor.
• Complete other duties as assigned.

Skills

Engineering degree

SPC tools

Lean Six Sigma

English comms

Interpersonal skills

Project management

Validation experience

MS Office

SAP knowledge

Education

Bachelor’s degree in engineering or equivalent

Tools

ERP systems (SAP)

CRM platforms

Statistical analysis tools

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.

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. 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 escalated 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

This 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.

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.

While performing the responsibilities of this role, the employee is expected to:

• 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.

Adverse exposure may include handling hazardous and biohazardous materials such as:

• Flammable and corrosive liquids

• Compressed gases

• Sharps

• Medical waste

Appropriate safety protocols and personal protective equipment (PPE) are required and provided. In accordance with the Americans with Disabilities Act (ADA), reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of the role.

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.

UNSOLICITED AGENCY SUBMISSION

Integra 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.

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.

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.

Integra LifeSciences 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].