Process Engineer II

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.

• Performtimelytechnical investigations, non-conformance, Failure Mode Effects Analysis (FMEA), and Corrective and Preventive Action (CAPA).

• Complete projects to drive process, quality, reliability and costimprovementsleveragingadvanced technologies,leansix-sigma tools and methodologies.

• Conduct time studies, process evaluations, and technical evaluations to align Bills of Materials, work instructions, and routers withprocessto ensure cost accuracy from product transfer through product lifecycle.

• Monitor performance metrics for value stream(s) and develop improvement actions necessary toattaintargeted 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 escalate 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 Sigmaexperience 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), QMSplatforms.

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 withthe 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 movethroughoutvarious areas of the building.

• Travel across all company locations as needed.

• Periodically lift and/or move items up totwenty-fivepounds.

• Travel domestically and internationally via car, train, or airplane, as required by the role.

ADVERSE WORKING CONDITIONS

The conditions listed below represent environmentalfactorswhich the employee may be exposedto whileperforming 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) arerequiredand provided.In accordance withthe 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 notrepresentan exhaustive list of all tasks that may berequired.Additionalduties may be assigned asappropriate tomeet business needs.

This job descriptiondoes notconstitutea 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:

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 [email protected].

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.

Integra - Employer Branding from Integra LifeSciences on Vimeo