Haemonetics · 1 day ago
Design Quality Engineer - Clinton, PA
Clinton, PA
Full-time
Onsite
Mid Level
3+ years expHaemonetics is a company focused on providing innovative solutions in the medical device industry. They are seeking a Design Quality Engineer to support the quality system by ensuring compliance with regulations and standards related to design control, while effectively collaborating with cross-functional teams on new product development and change management projects.
BiotechnologyConsultingHealth CareMedicalMedical Device
Responsibilities
Represent Quality department as cross-functional team member for product portfolios, new product development projects, and product change projects
Support detail tracking through project deliverables such as project quality plans and safety assessments and perform updates and release to documents within the electronic system
Participate in: Translation of Voice-of-Customer into development Requirements, Development, update, and release of various risk management documentation
Support development team in the creation, review, and approval of: Engineering Requirements & Specifications, Engineering test protocols and reports required for design verification, design validation
Define statistical sampling and testing methods required for verification and validation testing and provide measurement analysis support as required
Ensure accuracy and completeness of the Design History File and the Device Master Record
Ability to support multiple Product Line Portfolios
Provide quality engineering support for process development, implementation, improvement and validation efforts as assigned
Provide Post Market Surveillance complaint investigation technical support
Leading or participating in continuous improvement projects as well as improvements to policies, procedures, instructions, and training
Ensuring the ongoing readiness of the Quality Management System for external and internal audits and participating in audits and inspections as required
Ensuring compliance to and enforcement of applicable regulations, standards, Haemonetics policies / procedures
Qualification
Required
Minimum of 3 years medical device or IVD product development and design quality engineering experience
B.S. in Biomedical, Mechanical, Electrical or other appropriate Engineering degree
Good working knowledge of medical device design control process including risk management and design transfer
Strong team collaboration with ability to handle multiple tasks in a fast pace new product introduction environment
Manufacturing process validation knowledge and experience
Familiar with medical device Quality Management Systems
Company
Haemonetics
Haemonetics is a provider of blood and plasma supplies and services.
1001-5000 employees
H1B Sponsorship
Haemonetics 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 (2)
2024 (3)
2023 (3)
2022 (2)
2021 (4)
Funding
Current Stage
Public CompanyTotal Funding
$1.75B2024-05-21Post Ipo Debt· $600M
2021-03-01Post Ipo Equity· $435M
2019-05-23Post Ipo Equity· $10M
Leadership Team
Christopher Simon
President and Chief Executive Officer
Christopher Lindop
CFO and VP Business Development
Recent News
2026-01-03
2025-12-02
2025-11-21
Company data provided by crunchbase