Senior Biomedical Product Development Engineer – IVD Systems

Haemonetics; Boston (MA); On-site; USD 78,000 - 133,000; Full time

Benefits offered by this job

401(k) match

Employee stock purchase plan

Flexible time off

Paid holidays

Job summary

Haemonetics in Boston, MA is seeking an experienced Senior Biomedical Product Development Engineer to lead the mechanical design of disposable components for the TEG6s IVD system, impacting global clinical decision making.

You will own design controls, collaborate with QA, Regulatory, Manufacturing, and suppliers, and contribute to both new product development and sustaining engineering through full lifecycle.

Qualifications

• Bachelor’s degree in Bioengineering, Mechanical Engineering, or related technical field.
• Minimum of 5+ years in medical device, IVD, or regulated industry product development.
• Strong experience developing disposable components or capital equipment through full lifecycle (concept → production).
• Proficiency with SolidWorks CAD, BOM management, and PLM systems.

Responsibilities

• Lead the complete lifecycle of disposable device components, including concept development, detailed design, integration, and verification.
• Translate user and system needs into engineering requirements, specifications, and risk documentation.
• Develop and execute verification and validation (V&V) test protocols; analyze performance data to confirm design functionality.
• Generate high‑quality documentation for design controls, investigations, and regulatory submissions (510(k), PMA, technical files).

Skills

GD&T

MS Project

Smartsheet

Cross-functional collaboration

Education

Bachelor’s degree in Bioengineering or Mechanical Engineering

Tools

SolidWorks CAD

BOM management

PLM systems

Injection molding

Job description

Haemonetics in Boston, MA is seeking an experienced Senior Biomedical Product Development Engineer to lead the mechanical design of disposable components for the TEG6s IVD system, impacting global clinical decision making.

You will own design controls, collaborate with QA, Regulatory, Manufacturing, and suppliers, and contribute to both new product development and sustaining engineering through full lifecycle.