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Summary:

Haemonetics designs and manufactures medical devices that separate blood components (e.g. apheresis devices) for therapeutic treatments, pharmaceutical industry, blood transfusions, and other diagnostic equipment to support the healthcare blood management industry.

This is a key and critical role in the research and development team based at 125 Summer Street, Boston, MA. (5-minute walk from South Station) The qualified candidate will be a highly motivated Sr Mechanical Design Engineer for the overall concept, design, integration, reliability, and test of existing and next generation product enhancements. The candidate will be more than a Sr Mechanical Design Engineer, but also a Technical Leader who has demonstrated success in building technical foundational tools, infrastructure, and processes in the mechanical engineering discipline.

Your responsibilities will include, but not limited to the following:

• Design, develop, and maintain medical device platforms that separate blood components (e.g. apheresis devices) for therapeutic treatments, blood transfusions, pharmaceutical industry, and diagnostic equipment to support the healthcare blood management industry.
• Technical Leader in a wide range of engineering disciplines including Material selections, thermal management, electromechanical, mechanisms, safety medical standards (IEC/ISO 60601 standard series, IVD 61010 standard series, etc.) compliance, design for reliability and planning, mechanical verification, and etc.
• Lead cross-functional technical team discussions following our design control process from product requirements, designs, verification, and product release while meeting our customers demanding requirements.
• Lead technical discussions with key component suppliers in the areas of materials selection, critical to quality specifications, trouble shooting, DOE capability, etc.
• Demonstrated technical development success in translating Customer/User requirements/needs into reliable low-cost product designs and launch products to market successfully.
• GD&T & assembly or component tolerance analysis is a MUST.
• Design & build mechanical prototypes and prove design feasibility, functionality, and performance.
• Document all phases of the design including requirements, specifications, plans, reviews, test procedures, test reports, and various DFX disciplines (e.g., design for manufacturing, design for reliability, design for serviceability.)
• Lead existing product failure investigations: Investigate and determine root cause of product issues and use DOE method to implement solutions.

Requirements:

• BSME /MSME with 7+ years experience in Mechanical product design of complex electro-mechanical products in the medical device industry (or equivalent high reliability industries such as automotive, aerospace, military, etc.)
• Deep technical expertise across mechanical engineering disciplines, including plastics, metals, materials, thermal management, mechanisms, and reliability engineering
• Proven experience designing electromechanical medical devices from concept through production, including nextgeneration platform development
• Strong device architecture, subassembly placement, UX considerations, heat distribution, design for serviceability, and design for manufacturing
• Extensive handson expertise with SolidWorks (Complex assemblies, drawings, and PDM); SolidWorks proficiency is mandatory
• Demonstrated success in 2D/3D CAD design, simulations, tolerance analysis, and mechanical verification
• Experience executing full product development and prototype phases (LP, PP, PPQ) and transitioning designs to manufacturing.
• Strong application of DFM/DFA principles throughout development phases.
• Experience working closely with industrial design partners to translate UX requirements into robust mechanical solutions.
• Strong documentation capability, including system requirements, theory of operation, CAD drawings, test protocols and reports, risk analysis, and failure analysis
• Solid understanding of medical device regulatory requirements and standards (e.g., IEC/ISO 60601, IEC 61010), with experience supporting compliance activities and regulatory submissions
• Experience supporting manufacturing operations, including line layout, fixturing, kanban subassemblies, inline testing, and final device test strategies
• Demonstrated delivery of at least 1-2 complete electromechanical platform products from concept to production (medical device experience strongly preferred)

Preferred:

• Experience with thirdparty lab testing, simulation analysis, and certification for IEC safety and EMC compliance
• Knowledge of motor systems, motion control, and rotating machinery
• Knowledge of pneumatic systems, fluidhandling mechanisms, and thermal dynamics
• Broad familiarity with manufacturing processes including cables, shielding, and systemlevel electromechanical integration
• Experience driving continuous improvement initiatives to simplify designs, increase efficiency, and improve manufacturability

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: