Haemonetics

Haemonetics

Senior Product Development Engineer -Mechanical Engineering (Hybrid Boston)

Boston, MA, US · Senior

Sponsorship not specified$78k-$133kDetected 30 days ago
Data AnalysisProduct ManagementProject ManagementProcurementSolidWorksGD&TSystems EngineeringMechanical DesignFDA RegulatoryMedical DevicesResearchLeadershipCollaborationMentoring

About the role

  • We are seeking an experienced and creative‑thinking Senior Biomedical Product Development Engineer to join our multidisciplinary Research & Development Systems Engineering team in Boston, MA.
  • Your work will directly influence the accuracy, reliability, and usability of a platform used globally in clinical decision‑making.

Responsibilities

  • Design & Technical Leadership
  • Lead the complete lifecycle of disposable device components, including concept development, detailed design, integration, and verification.
  • Address complex design challenges balancing innovation, manufacturability, and timeline constraints.
  • 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).
  • Partner with QA, DQ, SQ, Clinical, Regulatory, Marketing, Procurement, and Manufacturing teams to support product success.
  • Work directly with global suppliers to support part development, validation, and production.

Requirements

  • Bachelor's degree in Bioengineering, Mechanical Engineering, or related technical field.
  • Proficiency with SolidWorks CAD, BOM management, and PLM systems.
  • Knowledge of plastics and metals fabrication (injection molding, lamination, laser welding, additive manufacturing, bonding).
  • Experience with microfluidic, cartridge ‑ based, or disposable diagnostic systems.
  • Proficiency with data analysis and DOE methodologies.
  • Familiarity with project management tools (MS Project, Smartsheet).
  • Working knowledge of FDA QSR, CE Marking, and ISO quality systems.
  • Basic wet ‑ lab proficiency supporting testing and system development.
  • 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 high ‑ volume manufacturing, cost optimization, and tolerance analysis.
  • Prior involvement in FDA 510(k), PMA, or CE submission processes.
  • Preferred Qualifications
  • Hands ‑ on iterative prototyping and test ‑ driven design experience.
  • Strong GD&T capabilities for drawing creation and interpretation.
  • Effective collaboration with cross ‑ functional partners and external suppliers.

Compensation

  • $78,400.00-$133,400.00/Annual
  • 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.

Benefits

  • 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.
  • 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.
  • Depending on your location, you may be eligible for more detailed information related to the compensation and benefits related to this job posting.

Company info

  • Employees may also be eligible to participate in the Company's long-term incentive plan, with eligibility and target amount dependent on the role.
  • Incentives may also be provided as part of Haemonetics' employee compensation.
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