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

Job Summary:

Support the quality system by ensuring compliance to and enforcing regulations, standards, policies, standard operating procedures, and instructions related to design control of Haemonetics products. Effective member of assigned cross-functional design teams supporting new product development and sustaining engineering change management.

Essential Functions:

SUPPORT NEW PRODUCT DEVELOPMENT & PRODUCT CHANGE MANAGEMENT PROJECTS BY:

• 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

SUPPORT QUALITY SYSTEM BY:

• 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

Qualifications:

• 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

EEO Policy Statement

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. Employees may also be eligible to participate in the Company’s long-term incentive plan, with eligibility and target amount dependent on the role.

In addition to compensation, the Company offers a competitive suite of benefits to its employees, including without limitation, a 401(k) with up to a 6% employer match and no vesting period, an employee stock purchase plan, “flexible time off” for salaried employees and, for hourly 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, and/or health and welfare benefits.

Depending on your location, you may be eligible for more detailed information related to the compensation and benefits related to this job posting. If you believe you may be entitled to such information by law, you may contact 1-781-348-7777, Monday through Friday, 7:30 a.m. – 5 p.m. ET or email AskHR@Haemonetics.com.

The base salary range for this role is: