Agiliti

Agiliti

Design Quality Engineer II

Kansas - Home based · Mid · Full-time

Sponsorship not specified$65k-$170kDetected 28 days ago
StatisticsProduct ManagementProject ManagementSupply ChainSolidWorksFDA RegulatoryMedical DevicesCommunicationCollaborationProblem SolvingWritingMicrosoft Office

About the role

  • Location for this role is flexible / can work remote when not traveling.

Responsibilities

  • Develops and maintains or supports the development of testing plans, models and methods for raw materials, materials in process, and finished goods.
  • Collaborates with Design, Manufacturing, and Supply Chain teams ensuring adequacy of product specifications to select and monitor suppliers.
  • Plans, develops, and oversees execution of Design verification and validation protocols.
  • Leads advanced product quality planning activities and assists in preparing new product designs for certification testing.
  • May lead mid-scale projects.

Requirements

  • Must be willing to travel to Design Center located in Milwaukee, WI and Manufacturing Sites in Kansas and California to participate in Design Reviews and other specific Design and Development Activities.

Nice to have

  • Bachelor's Degree (BS) in Engineering, Scientific, or Technical related subject required.
  • ISO13485 and FDA 21CFR820 highly desired.
  • Working knowledge and experience with metrology labs preferred and GD&T.
  • Working knowledge of IEC 60601-1 Safety standards preferred, but not required.
  • Use of statistical analysis software for SPC & CPk Analysis
  • Tooling and fixturing development and qualification (FAI and Gage R&R)
  • Minimum 3 years of working experience with Corrective and Preventive Actions at the Design and Development phase of a product lifecycle.

Skills

  • Proficient computer skills in MS Office Suite, including MS Project and Visio.
  • Working knowledge of CAD software preferred (i.e., SolidWorks, Autodesk, etc.)
  • Strong analytical skills and attention to detail
  • Strong technical writing skills and effective communication skills
  • Strong presentation, facilitation, and project management skills
  • High level knowledge of DFSS concepts and tools preferred, but not required.
  • This job description in no way states or implies these are the only duties to be performed by the employee in this position.
  • It is not intended to give all the details or a step-by-step account of the way each procedure or task is performed.
  • In addition, Agiliti will provide reasonable accommodations for qualified individuals with disabilities.
  • Affirmative Action Policy Statements
  • If vaccination is required, Agiliti will provide specific directions and cover the expense at a participating clinic.
  • Please note, this includes the COVID-19 vaccination.

Compensation

  • This range represents the low and high ends of the Agiliti pay range for this position.
  • This base pay range information is based on the market locations shown.
  • For sales positions, this range combines the base salary and the target incentive pay.
  • The actual pay offered may vary depending on several factors including geographic location, experience, job-related knowledge, skills, and related factors.
  • Dependent on the position offered, short-term and/or long-term incentives may be provided as part of the compensation.
  • $65,269.15-$169,742.88

Benefits

  • Leads activities to support medical device manufacturing, such as Risk Management, Process FMEA, and Quality Control Plans.

Company info

  • Location City:
  • Not Applicable
  • Location State:
  • Pay Range for All Remote Locations:
  • $65,269.15-$169,742.88
  • This range represents the low and high ends of the Agiliti pay range for this position.
  • This base pay range information is based on the market locations shown.
  • For sales positions, this range combines the base salary and the target incentive pay.
  • The actual pay offered may vary depending on several factors including geographic location, experience, job-related knowledge, skills, and related factors.
  • Dependent on the position offered, short-term and/or long-term incentives may be provided as part of the compensation.
  • Applicants should apply via Agiliti's internal or external career site.

This listing is sourced directly from Agiliti's careers page and normalized into a canonical job model.