Senior Product Develompent Engineer

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

Job Summary

We are seeking an experienced and creativethinking Senior Biomedical Product Development Engineer to join our multidisciplinary Research & Development Systems Engineering team in Boston this role you will serve as the primary owner of the mechanical design and functional performance of disposable components used within the TEG6s in vitro diagnostic (IVD) system. You will play a critical role across the full product lifecyclesupporting both new product development and sustaining engineering initiativeswhile collaborating closely with assay development manufacturing quality regulatory system hardware clinical and commercial teams to ensure robust product performance and successful market introduction. Your work will directly influence the accuracy reliability and usability of a platform used globally in clinical decisionmaking.

Key Responsibilities

Design & Technical Leadership

• 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.
• Address complex design challenges balancing innovation manufacturability and timeline constraints.

Execution Testing & Compliance

• Develop and execute verification and validation (V&V) test protocols; analyze performance data to confirm design functionality.
• Plan and conduct feasibility and prototype studies supporting both new development and sustaining efforts.
• Ensure compliance with internal SOPs and external standards including FDA QSR CE Marking and ISO requirements.
• Generate highquality documentation for design controls investigations and regulatory submissions (510(k) PMA technical files).

CrossFunctional Collaboration & Mentorship

• Partner with QA DQ SQ Clinical Regulatory Marketing Procurement and Manufacturing teams to support product success.
• Provide mentorship and technical guidance to junior engineers.
• Work directly with global suppliers to support part development validation and production.

Required Qualifications

• Bachelors 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).
• Expertise in design for highvolume manufacturing cost optimization and tolerance analysis.
• Proficiency with SolidWorks CAD BOM management and PLM systems.
• Knowledge of plastics and metals fabrication (injection molding lamination laser welding additive manufacturing bonding).
• Prior involvement in FDA 510(k) PMA or CE submission processes.

Preferred Qualifications

• Experience with microfluidic cartridgebased or disposable diagnostic systems.
• Handson iterative prototyping and testdriven design experience.
• Proficiency with data analysis and DOE methodologies.

Skills & Competencies

• Strong GD&T capabilities for drawing creation and interpretation.
  Familiarity with project management tools (MS Project Smartsheet).
• Working knowledge of FDA QSR CE Marking and ISO quality systems.
• Effective collaboration with crossfunctional partners and external suppliers.
• Basic wetlab proficiency supporting testing and system development.

What This Role Offers

• Ownership of critical components within a globally deployed diagnostic platform
• Opportunities to work at the intersection of engineering microfluidics and clinical diagnostics
• Collaboration with a highly skilled and missiondriven technical team
• Direct contribution to improving patient outcomes worldwide

EEO Policy Statement

Pay Transparency:

The base pay actually offered to the successful candidate will take into account without limitation the candidates 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 Companys 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- Monday through Friday 7:30 a.m. 5 p.m. ET or email .

The base salary range for this role is: