Katalyst CRO · 1 month ago
Quality & Design Engineer
Waukesha, WI
Full-time
Onsite
Mid LevelKatalyst CRO is a company focused on quality and design engineering, and they are seeking a Quality & Design Engineer to develop qualification plans for supplier transfer projects and manage engineering change requests. The role involves collaboration with engineering teams, managing design packages, and ensuring compliance with medical device quality management systems.
AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance
Responsibilities
Collaborate effectively within engineering and cross-functional teams
Pull together design packages including drawings, specifications, and Bill of Material (BOM)
Work with suppliers to understand requirements and answer technical questions
Drive design changes (ECOs) to add alternate supplier or change the approved supplier
Drive verification of transferred items and First Article Inspections (FAIRs)
Partner with Modality engineers to understand scope and impact of the transfer
Qualification
Required
Background in Electrical or Mechanical Engineering (mix of Mechanical & Electrical Engineers ideal)
Solid understanding of Medical Device Quality Management System (QMS) processes, with hands-on experience
Proven experience managing end-to-end design change projects
Electrical Engineering background, preferably with medical device knowledge
Design Change experience (Inputs, Requirements, Verification, Transfer)
Ability to read and interpret engineering specifications, drawings, and BOMs
Company
Katalyst CRO
Katalyst CRO | Advancing Healthcare & Life Sciences with Expert Research & Regulatory Solutions Katalyst Healthcare & Life Sciences (Katalyst CRO) is a Global Contract Research and Knowledge Process Outsourcing Organization (CRO) dedicated to driving innovation in research, regulatory compliance, and quality excellence for pharmaceutical, biotechnology, and medical device companies worldwide.
51-200 employees
H1B Sponsorship
Katalyst CRO has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (37)
2024 (14)
2023 (24)
2022 (52)
2021 (54)
2020 (39)
Funding
Current Stage
Growth StageLeadership Team
John Patil
Recruiter, Pharma/CRO Staffing Division
Recent News
2024-04-07
Company data provided by crunchbase