Haemonetics · 2 weeks ago
Senior Design Quality Engineer
Boston, MA
Full-time
Hybrid
Senior Level
$88K/yr - $119K/yr
7+ years expHaemonetics is a leading company in the medical device industry, constantly seeking to enhance its core talent. The Senior Design Quality Engineer will focus on software design and development, supporting new product development and managing engineering changes for embedded software within TEG and Plasma systems.
BiotechnologyConsultingHealth CareMedicalMedical Device
Responsibilities
Represent Quality department as cross-functional team member for product portfolios, new product development projects, and product change projects
Support development team in creation, review, and approval of Software engineering Requirements & Specifications in accordance with standard operating procedures
Lead cross-functional teams in the development, update, and release of Software risk management documentation inclusive of but not limited to: Hazard Analysis, Risk Management Plan & Report, FMEA’s (Use, Design & Process), Fault Tree Analysis (FTA)
Lead or support development team in creation, review, and approval of engineering development plans & test plans
Support development team in creation, review and approval of software engineering test protocols and reports in support of software verification, software validation and system validation
Support development team in creation, review, and approval of traceability of user requirements, software engineering specifications, and software verification & validation testing
Ability to support any Product Line Portfolios and actively supports 1 or more Product Line Portfolios
Ensure accuracy and completeness of the Design History File and the Device Master Record
Compile, review, and analyze failure data to provide feedback to the development team
Mentor, develop, coach, and / or supervise less experienced quality engineers
Ensuring compliance to and enforcement of all required elements from regulations, standards, policies, standard
Supporting and administering quality system elements including but not limited to: Design Controls, CAPA, Non-Conformance, Complaint, Deviation, Document Controls, Labeling, etc
Lead continuous improvement projects and reviews of policies, procedures, instructions, and training
Ensure the ongoing readiness for and participate in any potential internal/external audits and inspections
Lead or participate in problem solving and other work improvement activities
Qualification
Required
Minimum of 7 years medical device or IVD product development and design quality engineering experience
Excellent Organization skills
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
Travel to company sites as required
Effective communication, presentation and collaboration skills
Proficient with office, planning and analysis software tools
Benefits
401(k) with up to a 6% employer match and no vesting period
Employee stock purchase plan
Flexible time off for salaried employees
Accrual of three to five weeks’ vacation annually (based on tenure)
Accrual of up to 64 hours (annually) of paid sick time
Paid and/or floating holidays
Parental leave
Short- and long-term disability insurance
Tuition reimbursement
Health and welfare benefits
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