Senior Process Engineer I

INTEGRA LIFESCIENCES CORP; West Valley (WA); On-site; USD 85,000 - 110,000; Full time

Job summary

INTEGRA LIFESCIENCES CORP is seeking a Senior Process Engineer in Washington to optimize and sustain manufacturing processes using Lean and Six Sigma methodologies. You will develop cross-functional networks, lead engineering projects, and ensure compliance with regulatory requirements.

The ideal candidate has a Bachelor’s degree in engineering with at least 5 years of experience, proficiency in statistical process control, and excellent communication skills. This role offers an opportunity to drive significant improvements in manufacturing processes.

Qualifications

• 5+ years of experience in engineering required.
• Master's degree with 3+ years of experience is preferred.
• Experience with statistical process control tools required.

Responsibilities

• Develop and implement engineering studies and validations.
• Leverage statistical process control to improve manufacturing yields.
• Lead cross-functional project teams on process improvements.

Skills

Statistical process control

Lean Six Sigma

Project management

Microsoft Office

Interpersonal skills

Organizational skills

Education

Bachelor's degree in engineering

Master's degree in engineering

Tools

ERP systems (e.g., SAP)

Statistical analysis tools (e.g., Minitab)

Project management software (e.g., MS Project, Jira)

QMS platforms

Job description

The Senior Process Engineer is responsible for understanding, optimizing, and sustaining 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 enhance process efficiency. The role focuses on end‑to‑end process and product understanding, lifecycle sustaining engineering changes, and ensuring compliance with corporate policies and regulatory requirements (FDA, GMP, ISO 9001, ISO 13485, EU MDR, Canadian Medical Device Regulations, and others).

Key Responsibilities

• Develop a cross‑functional network with Environmental, Health & Safety (EHS), product development, process technology, Centers of Excellence (CoEs), facilities, quality, regulatory, planning, and procurement to address process challenges, change requests, and lifecycle and sustaining changes.
• Represent value stream teams in strategic site and enterprise projects on cross‑functional teams addressing quality improvements, lifecycle management efforts, and new product introductions.
• 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, inputs and outputs, improve manufacturing yields, reduce scrap, and error‑proof manufacturing processes.
• Perform timely technical investigations, non‑conformance, Failure Mode Effect Analysis (FMEA), and Corrective and Preventive Action (CAPA).
• Identify, financially justify, and lead projects to drive process, quality, reliability and cost improvements using advanced technologies, lean Six Sigma tools, and methodologies.
• Ensure value stream(s) BOMS, routers, and work instructions align with process requirements and maintain cost accuracy from product transfer through product lifecycle.
• Complete process improvement actions to ensure performance metrics meet targeted Key Performance Indicators (KPIs).
• 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.

Qualifications and Competencies

• 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, or equivalent software).
• Lean Six Sigma experience required.
• Excellent organizational and English communication skills (oral & written).
• Sound interpersonal and employee development skills.
• Project management and process improvement experience; PMP certification desired.
• Knowledge of enterprise resource planning, material resource planning, and Microsoft 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

In accordance with the Americans with Disabilities Act (ADA), reasonable accommodations may be made to enable individuals with disabilities to perform these duties. 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 or move items up to twenty‑five pounds, and travel domestically and internationally by car, train, or airplane as required.

Adverse Working Conditions

• Handling hazardous and biohazardous materials such as flammable and corrosive liquids, compressed gases, sharps, and medical waste.
• Adherence to appropriate safety protocols and personal protective equipment (PPE) requirements.

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.