Senior Process Engineer

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.

About the role

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 for process efficiency. They develop end-to-end process and product understanding, control and address lifecycle management, and sustaining engineering changes. Duties are executed 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

• Work 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.
• Design, specify, develop, and purchase manufacturing tooling, fixtures, and equipment.
• Manage the implementation and validation of new or modified manufacturing processes and equipment to support the manufacture of Integra products.
• Support and guide transfers internally within plant and externally with suppliers.
• Write and implement Manufacturing Procedures and Work Instructions.
• Create, update, and maintain BOMs, Routers, and DMRs.
• Act as a recognized manufacturing and process technical expert, providing process engineering knowledge and oversight to resolve manufacturing-related problems with existing products and processes.
• Champion improvement processes for rework, scrap, and labor variance reduction/elimination in plant processes.
• Support the Material Review Board process by investigating and resolving manufacturing and supplier quality concerns.
• Identify and provide innovative new manufacturing technologies from industry best practices that can be applied to Integra products and manufacturing processes.
• Represent 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, and procurement to address process challenges, material changes, 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.
• 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 analysis and trending of existing process parameters, process inputs and outputs, to improve manufacturing yields, reduce 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 processes to ensure cost accuracy from product transfer through the product lifecycle.
• Monitor performance metrics for value stream(s) and develop improvement actions necessary to attain targeted Key Performance Indicators (KPIs).
• 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.

Requirements

• 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, PQ 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 of how to troubleshoot and analyze the 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 is preferred.
• Experience in Lean Manufacturing 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.

Location & Schedule

Position is located in Mansfield, MA and requires onsite presence 40 hours per week. Ability to travel up to 10% domestically is required.

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.

• Sit, listen, speak, and move throughout various areas of the building.
• 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.
• Regular use of tools and equipment relevant to the work environment, including:
  • 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.

Adverse Working Conditions

The conditions listed below represent environmental factors the employee may be exposed to while performing the essential duties of this position. These reflect a general plant or service environment.

• 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.

Pay

Salary Pay Range: $81,650.00 - $112,700.00 USD. 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.

Benefits

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
• Group legal insurance
• Savings plan (401(k))

Subject to the terms of their respective policies and date of hire, employees are eligible for additional Total Rewards programs.