Senior Process Engineer I

Integra LifeSciences Corporation; Montana; On-site; USD 71,000 - 98,000; Full time

Benefits offered by this job

Health insurance

401(k) plan

Dental insurance

Job summary

Integra LifeSciences is hiring a Sr. Process Engineer to optimize and sustain manufacturing processes, ensuring compliance with GMP, ISO 9001, ISO 13485, EU MDR, CMDR and other regulatory standards.

The role emphasizes cross-functional collaboration, process validation, and lifecycle management across value streams. Requires a Bachelor’s in engineering and 5+ years of experience; Lean Six Sigma and SPC skills are essential.

Qualifications

• Bachelor’s degree in engineering or equivalent; 5+ years of experience; Master’s degree with 3+ years is a plus.
• Experience with SPC, Minitab or other stats software.
• Lean Six Sigma experience required; PMP desired.

Responsibilities

• Develop cross-functional network with EHS, product development, and facilities to address process challenges and lifecycle changes.
• Represent value stream teams in site and enterprise projects on cross-functional teams for quality improvements and lifecycle management.
• Initiate and execute IQ/OQ/PQ/TMV validations and Engineering Change Requests/Orders (ECR/ECO).
• Leverage SPC to analyze process parameters and improve yields while reducing scrap and errors.
• Lead CAPA investigations and drive cost, quality, and reliability improvements.

Skills

SPC experience

Lean Six Sigma

English communication

Project management

Regulatory awareness

Education

Bachelor’s degree in engineering or equivalent

Master’s degree (preferred)

Tools

SAP ERP

MS Project

Jira

Job description

US-UT-West Valley-106-Facility

Full time

JR-5993

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 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 are responsible for end-to-end process and product understanding and control and manage managing lifecycle 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.

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

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.

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.

#LI-EM1

Salary Pay Range:

$71,000.00 - $98,000.00 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 (https://www.integralife.com/careers/total-rewards)

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 (https://www.eeoc.gov) | EOE including Disability/Protected Veterans (https://www.eeoc.gov/eeoc/publications/ada_veterans_employers.cfm)

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 (https://www.eeoc.gov/eeoc/publications/fs-ada.cfm) . If you have difficulty using our online system due to a disability and need an accommodation, please email us at [e-mail].

Whatever your specialty, you’ll find an ideal setting for building a rewarding career.

Along the way, you’ll have the satisfaction of knowing your work matters, that it’s making patients’ lives better, making a positive and lasting difference. You’ll find that the pace is exhilarating – because the need is so urgent. You’ll be challenged – and supported – by the most dynamic and inspiring people in your profession. And you’ll grow a career that is more impactful and fulfilling then you thought possible. More than 4,200 Integra employees already know we’re a great place to build a career. Here’s your chance to discover that for yourself.