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

Haemonetics is seeking an experienced Systems Engineer to work within a multidisciplinary product development team specifically focused on in-vitro diagnostic and medical device systems. If you are seeking a career that both challenging and rewarding in a work environment that is diverse and dynamic, look no further — Haemonetics is your employer of choice.

As member of the Systems R&D team, systems engineering collaborates with cross-functional team members to define and continuously improve our TEG product platform through requirements definition to commercialization, ensuring compliance with regulatory standards and quality systems for both new products and sustaining engineering support of existing products.

The position works within a team to define and translate user needs into product requirements, establish & maintain requirements trace matrices, as well as generate and execute system characterization and system performance test protocols. Systems engineering provides input to and supports risk management activities and also supports regulatory filings with provision of analytical performance reports, technical input and review, risk assessments, and compliance with standards. Effective communication and facilitation of cross-functional problem-solving are essential duties. Routinely interacting with technical and cross-functional team members is part of the responsibility. Some customer and supplier interaction may also be required. This rloe is Hybrid onsite at 125 Summer St in downtown Boston.

Key Responsibilities:

• Contribute to the iterative process of defining and translating user needs to product requirements and assist in translating requirements into design specifications.

• Develop and review test protocols, ensuring traceability to requirements and specifications.

• Identify and mitigate risks through design, development, and testing strategies.

• Provide technical support for regulatory submissions, including gap analysis and test proposals.

• Facilitate group problem-solving and decision-making activities.

• Communicate risks and mitigation strategies during project planning.

• Analyze data and evaluate the applicability of technical recommendations.

• Coordinate work across project teams and departments with proactive communication.

• Maintain sensitivity in communications with culturally diverse audiences.

• Apply advanced knowledge of specialized disciplines to support product needs and customer requirements.

Qualifications/ Experience:

• Education: Bachelor’s degree in electrical, mechanical, biomedical, computer engineering, or equivalent is required.

• Experience: At least 5 years of hands-on technical experience in complex multidisciplinary product development, including one large product through its full development lifecycle.

• A minimum of 2 years’ experience in medical device or in-vitro diagnostic (IVD) development under FDA Quality Systems Regulations, CE Marking, and ISO Quality System

• Preferred Training and Skills

• Systems thinking approach considering the product lifecycle, environment, users and stakeholders.

• Practical knowledge of requirements and risk management strategies and approaches

• Strong technical and leadership skills within the applicable discipline.

• Excellent interpersonal and administrative skills.

• A continuous improvement mindset.

• Systems engineering training or certification preferred.

• Some training or certification in Six Sigma methodologies preferred.

Physical Demands and Travel:

• Physical activities include sitting, standing, walking, reaching, stooping, kneeling, and crouching.

• Ability to lift or move up to 10 pounds.

• Exposure to moving mechanical parts, vibration, moderate noise levels, hazardous chemicals, and blood.

• Occasional travel expected, ranging from 10% to 25%.

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: