Manage key relationships with external manufacturers, acting as the main technical liaison for communications and operational performance.
Lead cross-functional end-to-end process solution deployment, from feasibility to verification/validation for Instrument Manufacturing & Assembly processes (catheter and other devices), including, but not limited to lamination, braiding, tipping, soldering, final inspection, pouching/boxing/label printing, reprocessing and sterilization processes.
Document and execute equipment/process validation protocols & reports.
Drive continuous improvement with multiple external manufacturers to enhance product line performance and reliability.
Serve as a point of escalation for issues, facilitate timely resolution and minimizing operational disruptions
Lead mitigations to resolve root cause, provide recommendations and may lead NCR’s and CAPAs depending on the need or root cause.
Provide strategic project oversight to support long-range planning and capacity to meet future demand requirements.
Perform analysis of investments requirements to support recurring cost reductions and business growth.

Requirements

A minimum of a Bachelors degree in an Engineering discipline.
8+ years professional experience outside of degree program.
Knowledge of good manufacturing practices and documentation.
Excellent written and oral communication skills.
Experience in a regulated industry; medical device experience is a plus.
Knowledge of computer programs in addition to Microsoft office products.
Self-starter with a desire to engage in proactive learning.
Must be highly organized with the ability to drive projects/tasks simultaneously and effectively prioritize projects and tasks
Experience in process/product validations.

Benefits

Vacation –120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
Holiday pay, including Floating Holidays –13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave – 80 hours in a 52-week rolling period
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

process validationequipment validationmanufacturing processeslaminationbraidingtippingsolderingfinal inspectionpouchingsterilization

Soft Skills

communication skillsorganizational skillsproblem-solvingproject managementleadershipcontinuous improvementself-starterproactive learningprioritizationrelationship management