Senior Design Quality Engineer

Boston, NH - USA

Monthly Salary: $ 87892 - 118774

Posted on: 14 hours ago

Vacancies: 1 Vacancy

Job Summary

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 but

not limited to: Hazard Analysis Risk Management Plan & Report FMEAs (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.

EEO Policy Statement

Pay Transparency:

The base pay actually offered to the successful candidate will take into account without limitation the candidates 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 Companys 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- Monday through Friday 7:30 a.m. 5 p.m. ET or email .

The base salary range for this role is:

$87892.99-$118774.78/Annual

Required Experience:

Senior IC