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Boston Scientific · 1 month ago

Design Quality Engineer II

Maple Grove, MN

Full-time

Hybrid

Mid Level

$70K/yr - $132K/yr

3+ years exp

Boston Scientific is a leader in medical science, committed to solving important health industry challenges. The Design Quality Engineer II will support single-use devices and capital equipment, ensuring compliance with design controls and facilitating organizational success by maintaining product quality and patient safety.

Health CareMedicalMedical Device

No H1B

Responsibilities

Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues

Develops and executes plans for design control and risk management of complex projects

Update and maintain risk management files, such as the Hazard Analysis, Task Analysis, and Design FMEA

Working knowledge of Design Controls. Provide design quality and compliance input to project teams for project decisions and deliverables (i.e., Design Change Analysis, Design Inputs, Design Outputs, Test Methods, Design Reviews, Design V&V, Usability Testing, SW Validation, Process Validation and Labeling)

Promotes and influences compliance to BSC’s quality, business and health & safety systems and market/legal regulations

Checks and provides support in the execution and investigation of CAPAs, NCEP, Failure Mode Investigations, etc

Demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedure

Qualification

Design ControlsRisk ManagementQuality System RequirementsClass III Medical DevicesCorrectivePreventive ActionCommunication SkillsTeam CollaborationProblem Solving

Required

Bachelor's degree in engineering or science discipline, or equivalent

3+ years experience in design assurance, quality, or related medical device or regulated industry experience

Knowledge of basic Quality System Requirements and Good Documentation Practices

High energy problem solver capable of driving items to closure

Adaptable and effective collaborator in a team environment and in self-directed work

Strong communication skills (verbal & written)

Preferred

Experience with Class III Medical Devices

Experience with Capital Equipment

Experience with design control, risk management, and medical device standards compliance

Experience with corrective and preventive action

Benefits

Relocation assistance is available for this position.

Compensation may also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).

Compensation may also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).