The Senior 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, 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.

Responsibilities

• Works within cross-functional project teams including Quality Assurance, Supplier Quality, Planning, Purchasing, Regulatory, and Manufacturing to maintain and improve manufacturing processes used to manufacture surgical products for the medical device industry.
• Designs, specifies, develops, and purchases manufacturing tooling, fixtures and equipment.
• Manages the implementation and validation of new or modified manufacturing processes and equipment to support the manufacture of lntegra products.
• Support and guide transfers internally within plant and externally with suppliers.
• Writes and implements Manufacturing Procedures and Work Instructions.
• Creates, updates and maintains BOMs, Routers, and DMRs.
• Works as a recognized manufacturing and process technical expert who can provide process engineering knowledge and oversight to resolving manufacturing-related problems with existing products and processes.
• Champions improvement processes for rework, scrap, and labor variance reduction / elimination in the plant processes.
• Supports Material Review Board process by investigating and resolving manufacturing and supplier quality concerns.
• Identifies and provides innovative new manufacturing technologies from industry best practices that can be applied to lntegra products and manufacturing processes.
• Represents the Manufacturing Engineering group on strategic projects in Manufacturing and Sourcing.
• 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.

• 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.

• Complete other job-related duties as assigned.

Skills & Competencies

• Bachelor's degree in Mechanical, Manufacturing, Materials or Biomedical Engineering or equivalent is required.
• A minimum of 5 years of engineering industry experience is required.
• Experience in the medical device industry is required.
• Knowledge of GMPs, ISO 13485 Design Control, and Manufacturing Process IQ, OQ, PO qualifications as related to medical devices is required.
• Working knowledge in manufacturing processes such as metal processing (machining, polishing, welding), plastics processing, and mechanical assembly is required.
• Working knowledge of machine and tool design, equipment design, and the startup of new equipment is preferred.
• Experience working in a cleanroom environment is preferred.
• Assist on blackbelt/greenbelt projects as needed. Assist with tools and Minitab software.
• Knowledge on how to troubleshoot and analyze effectiveness of manufacturing processes is required. Experience in implementing actions to improve equipment uptime, yield, efficiencies, and quality of production is required.
• Proficiency in 2D/3D CAD preferred
• Experience in Lean MFG and Continuous Improvement Methods is preferred.
• Knowledge of financial accounting and analysis methods to assess product standard costs, project values, product cost improvements and capital purchases is required.
• Strong communication, team building, and cross-functional coordination skills are required.
• Experience with Agile and Oracle data systems is preferred.
• Position is located in Mansfield, MA and requires onsite presence 40 hrs week.
• Ability to travel up to 10% domestically is required.

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.
• Required to work in a cleanroom environment requiring gowning, standing and adherence to protocols
• 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.

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