External Manufacturing Technical Lead

Full-stack EngineerSoftware EngineerFull TimeRemoteTeam 1,001-5,000H1B SponsorCompany Site LinkedIn

Location

California + 1 more

Posted

29 days ago

Salary

$109K - $174.8K / year

Bachelor Degree8 yrs expEnglishAssembly

Job Description

• 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.

Job 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