Principal Design Quality Engineer

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:

Principal Design Quality Engineer will provide leadership in the design and implementation of world-class quality engineering to support activities such as reliability, risk management, analytics/statistical techniques, requirements management, verification and validation, and design control. Activities would drive prevention, detection of defects at the earliest phase of product design, continuous improvement and customer satisfaction.

REQUIREMENTS:

- Provide Quality leadership for new product development and product change management for:
Provide leadership, and technical expertise to ensure conformance to ISO, FDA (Food & Drug Administration) & MDD (Medical Devices Directive) based quality systems. Support global product registration needs by acting as the liaison for technical questions as it pertains to design control and compliance to external standards.
- Provide leadership & support to process excellence initiatives including Six-sigma, design excellence & lean thinking.
- Represent Quality department as a cross-functional team member for product portfolios, new product development projects, and product change projects.
- Manage project quality plans.
Lead or participate in the translation of Voice-of-Customer into development Requirements.
- Support the development team in the creation, review, and approval of engineering Requirements & Specifications in accordance with standard operating procedures.
- Lead cross-functional teams in the development, update, and release of 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 the development team in the creation, review, and approval of engineering development plans & test plans.
- Support the development team in the creation, review, and approval of engineering test protocols and reports in support of design verification, design validation, and process validation.
- Lead the development team in creation, review, and approval of critical-to-quality specifications.
Support development team in the creation, review, and approval of traceability of user requirements, engineering specifications, and verification & validation testing.
- Lead measurement systems analysis for acceptability and develop, support, & approve validation protocols and reports for test methods.
- Define statistical testing methods and sampling in support of verification and validation testing.
- Ability to support any Product Line Portfolios and actively support 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:

- Provide leadership & support to process excellence initiatives including Six-sigma, design excellence & lean thinking.
- Ensuring compliance to and enforcement of all required elements from regulations, standards, policies, standard operating procedures, and instructions.
- 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.

QUALIFICATIONS:

- BS in Engineering in Electrical, Biomedical, Mechanical, other equivalent technical engineering discipline required (Advanced degree, Masters or PhD, substitute 2 years experience below)
- 8 years in a medical device or equivalent regulated environment.
- 8 years Design Quality Engineering or equivalent design experience required Professional certification as one or more of the following:
- Certified Quality Engineer, Certified Reliability Engineer, Certified Six Sigma Black Belt

Pay Transparency:

The pay range for this role is:

$103,600.00-$176,400.00/Annual

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 [email protected] .

Applicants must be legally authorized to work in the United States. Haemonetics will not provide employment visa sponsorship for this position, either now or in the future.

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