Process Engineer

Position: Process Engineer I
Location: Plainsboro

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.

SUMMARY

The Process Engineer I 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 and 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.

This position will support the Tendon Value Stream.

KEY RESPONSIBILITIES

* 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.

* Respond to immediate escalations from manufacturing floor and escalate to leadership, as needed.

* Complete other job-related duties as assigned.

Skills & Competencies

* Bachelor's degree in engineering or equivalent with 0-2 years of experience.

* Statistical process control tools desired (SPC, Minitab, other software).

* Lean Six Sigma experience desired.

* Demonstrate excellent organizational and English communication skills (oral & written)

* Positive, sound interpersonal, and employee development skills

* Project management and process improvement experience desired

* Knowledge in 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…