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. This position would support the Skin Value Stream.
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.
- Respond and resolve immediate escalations from manufacturing floor and escalate to leadership as needed.
- 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.
- Experience generating and executing validations, cleaning validation experience is desired.
- 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
Appropriate safety protocols and personal protective equipment (PPE) are required and provided.
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:
$81,650.00 - $112,700.00 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 trainingIn addition to base pay, employees may be eligible for bonus, commission, equity or other variable compensationYour 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
