Senior Design Quality Engineer

Senior Design Quality Engineer page is loaded## Senior Design Quality Engineer locations:
Boston, MA, UStime type:
Full time posted on:
Posted Todayjob requisition :
R10070

We are constantly looking to add to our core talent. If you are seeking a career that is challenging and rewarding, a work environment that is diverse and dynamic, look no further — Haemonetics is your employer of choice.## Job Details The Senior Design Quality Engineer specializing in Software design and development will work as a member of the cross-functional design team supporting new product development and sustaining engineering change management for embedded software within the TEG and Plasma systems.
* SUPPORT NEW PRODUCT DEVELOPMENT & PRODUCT CHANGE MANAGEMENT BY:
* • 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 butnot 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
* • SUPPORT QUALITY SYSTEM BY:
* • 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
*
* Qualifications:

*** 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.
** Pay Transparency:
** The base pay actually offered to the successful candidate will take into account, without limitation, the candidate’s location, education, job-knowledge, skills, and experience in prior relevant roles. Incentives may also be provided as part of Haemonetics’ employee compensation. For sales roles, employees will be eligible for sales incentive (i.e., commission) under the applicable plan terms. For non-sales roles, employees will be eligible for a discretionary annual bonus, the target amount of which varies based on the applicable role, to be governed by the applicable plan terms.

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