Sr. Process Development Coordinator

By living according to a common set of values, we create a culture that unifies, embraces the uniqueness we all bring to the company, and positions Integer for long-term success.

At Integer, our values are embedded in everything we do.

Customer

We focus on our customers’ success

Innovation

We create better solutions

Collaboration

We create success together

Inclusion

We always interact with others respectfully

Candor

We are open and honest with one another

Integrity

We do the right things and do things right

The primary purpose of this job is to coordinate and centralize technical documentation and project timelines to support the Process Development (PD) team. Coordinates the development, maintenance and updates for PD documentation, including (but not limited to) protocols, reports, records and procedures created during development. Coordinates the creation of, alignment to and status updates for PD project schedules across the whole of the PD team.

Accountabilities & Responsibilities:

• Adheres to Integer’s Values and all safety, environmental, security and quality requirements including, but not limited to: Quality Management Systems (QMS), Safety, Environmental and Security Management Systems, company policies and operating procedures, and other regulatory requirements.
• Coordinates project timelines across the PD team, identifying critical path as well as constrained resources.
• Works with PD team to ensure timelines quoted to customers are met or the changes are communicated prior to due dates.
• Works with PD team to make adjustments when resource constraints are identified/met during timeline planning and execution.
• Coordinates with respective departments for necessary communications when timelines are impacted.
• Coordinates the change request process, for the PD team, within the electronic change control system following documented quality and change control processes, such as the following during the development process:
  • Performing the creation of and/or updates to product and process documentation, following and improving documentation standards.
  • Tracking changes: Creates, routes and monitors the change requests for product and process documentation.
  • Implementation: Ensures a smooth implementation of approved changes.  Including coordinating with various teams, such as engineering, production and quality.
  • Problem Solving: When issues arise during the change process, the coordinator will help troubleshoot and find solutions.  Collaborates with the relevant stakeholders to address any challenges.
• Coordinates with respective departments for creation of and editing drawings, bills of materials, routings and other applicable documentation.
• Verifies completeness and accuracy of provided documentation/data and resolves discrepancies with the appropriate persons.
• Ensures documentation meets applicable and required standards (Ex. Good Manufacturing Practice (GMP), Quality System Regulation (QSR), etc.).
• Analyzes and develops solutions to improve current processes.
• Participates in the creation of new processes to improve the Quality System in relation to development processes.
• Assists PD team and executes project work as assigned.
• Assists in maintaining respective project documentation and records.
• Performs other duties as required.

Education & Experience:

• Minimum Education: HS Diploma.
• Minimum Experience: 7-10 years’ experience in an operations environment, medical device operations experience preferred

Knowledge & Skills:

• Special Skills:
  • Highly organized, detail oriented and quality minded
  • Ability to work independently, prioritize and ensure tasks are completed
  • Strong written and oral communication
  • Proficiency with MS Office products such as Word and Excel
  • Ability to read technical drawings
  • Experience working with cross-functional teams

• Specialized Knowledge:
  • Documentation/change control experience
  • Working knowledge of Oracle or similar ERP Platforms
  • Knowledge/experience with ISO13485 desirable
  • Working knowledge/experience with MS Project is preferred.
  • Working knowledge with conferencing software (Video, WebEx, Cisco, etc.)
  • Knowledge/experience with product development life cycle processes
• Senior Process Development Coordinator Salary: $52,800- $77,000

U.S. Applicants: EOE/AA Disability/Veteran