Senior Systems Engineer (Boston Hybrid)

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%.