Consumable Product Development Engineer II

Haemonetics • Boston, MA

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About The Position

Haemonetics is seeking a Consumable Product Development Engineer II to support the design, testing, and verification of disposable and consumable components used in regulated diagnostic systems. This role is execution-focused and highly hands-on, translating user needs and product requirements into viable design solutions and leading development and testing of new design concepts and design improvements. Activities include generation of prototypes, execution of feasibility evaluations and design verification & validation testing, leading risk assessments, and documenting selected design solutions. The position emphasizes rigorous application of experimental design, data analysis & interpretation, independent problem solving, and clear communication of results within a regulated medical device development environment. Operates with moderate independence, requiring minimal day-to-day technical supervision while escalating strategic or architectural decisions appropriately. This position will support both sustaining activities and new product development. Expanded Scope Specific to TEG 6s Systems Acts as a technical Subject Matter Expert (SME) within consumable R&D for assigned subsystems, driving mechanical and systems-level improvements to existing and next-generation TEG 6s cartridges and associated disposable components. Leads evaluation of consumable–instrument interactions including resonance mechanics, microfluidic flow behavior, optical signal detection, clot-mechanics measurement performance, and system robustness. Demonstrates strong understanding of TEG 6s system architecture and how consumable design influences instrument-level performance, assay reliability, manufacturability, and field performance. Independently analyzes experimental data, develops technical conclusions, and determines applicability of recommendations to product performance and regulatory compliance. Serves as subsystem-level technical owner for defined consumable components, accountable for technical execution from feasibility through verification.

Requirements

• Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, or related field
• 2–4 years of experience in product development, test engineering, or R&D
• Demonstrated hands-on experience with prototyping, testing, and advanced data analysis
• Ability to independently design, execute, and interpret experiments with strong technical judgment
• Strong written and verbal communication skills, including technical presentation of data to diverse audiences
• Working knowledge of regulated medical device development processes, including design controls and verification methodology
• Demonstrated ability to independently own defined technical scope within a regulated development program.

Nice To Haves

• Master’s degree in an engineering or life-sciences discipline
• Experience in regulated product development (medical device, diagnostics, or similar)
• Familiarity with CAD tools (SolidWorks preferred)
• Experience leading verification and validation efforts
• Working knowledge of statistical analysis and data visualization tools
• Experience with system-level diagnostic device development involving consumable–instrument interaction

Responsibilities

• Consumable Design & Development Lead concept evaluations, translating VOC and user needs gathered from customer, clinical, and internal feedback into feasibility models and prototypes.
• Drive design updates and improvements to consumable components and subsystems, with a focus on performance, usability, manufacturability, cost, and field reliability.
• Develop and refine component- and system-level requirements and specifications.
• Design and build fixtures to measure and characterize fundamental physical processes of consumables and their interactions with the instrument, including optics, resonance, microfluidics, and surface–blood interactions.
• Develop and evaluate new materials, subcomponents, and test fixtures from feasibility through design verification.
• Interface directly with suppliers, manufacturing, Quality, Systems, and Software to ensure technically sound integration of consumable design within the overall TEG 6s system.
• Contribute to cross-functional technical decision-making and provide data-driven recommendations influencing project direction.
• Mentor junior engineers or technicians on experimental design, lab execution, and data interpretation as appropriate.
• Design Evaluation, Verification and Validation Lead feasibility and design evaluations to assess requirements and define product specifications.
• Develop complex test protocols; review and provide technical feedback on protocols developed by others.
• Execute rigorous verification and validation testing to demonstrate that design outputs meet defined requirements.
• Design experiments with appropriate controls, statistical rigor, sample sizes, and acceptance criteria.
• Independently solve complex and diverse technical problems, evaluating short- and long-term impact of recommendations on product performance and regulatory compliance.
• Research issues beyond immediate technical scope and select the most efficient investigative methods to achieve objectives.
• Develop novel test methods and evaluation techniques where existing methods are insufficient.
• Analyze test data, interpret results, draw technically sound conclusions, and define evidence-based next steps.
• Prepare structured technical summaries suitable for design reviews, regulatory documentation, and executive decision-making.
• Identify technical risks proactively and drive mitigation strategies in collaboration with Quality and Systems teams.
• Prototyping & Testing Execution Build, source, and evaluate feasibility models and prototypes in collaboration with internal teams and external suppliers.
• Perform bench- and system-level testing and document outcomes in accordance with internal procedures and design control requirements.
• Lead investigations of performance trends, anomalies, and failure modes using structured root-cause methodologies.
• Maintain laboratory readiness, including fixture calibration, equipment maintenance, and adherence to proper biohazard handling and laboratory best practices.
• Independently prioritize lab activities and testing timelines to meet program milestones.
• Documentation & Design Controls Own controlled documentation including test protocols, test reports, specifications, and design records.
• Drive BOM updates, drawing revisions, and engineering change documentation in accordance with internal SOPs and quality system requirements.
• Apply FDA Quality System Regulations (QSR), ISO 13485, CE marking requirements, and internal medical device development processes throughout the product lifecycle.
• Ensure technical traceability from user needs through verification evidence.
• Develop familiarity with patent policies, competitive landscape, and intellectual property considerations relevant to consumable development.
• Support audit readiness activities and provide technical rationale during internal or external audits as required.
• Communication & Cross-Functional Collaboration Provide clear written and oral technical presentations to senior engineers, leadership, Quality, Manufacturing, and external stakeholders as required.
• Collaborate cross-functionally to ensure consumable design changes are technically robust, manufacturable, compliant, and aligned with business objectives.
• Independently lead defined technical projects or major workstreams within larger programs where speed, quality, and technical depth significantly impact results.
• Influence without authority across functions by grounding recommendations in strong technical evidence.

Benefits

• 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
• health and welfare benefits

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level