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Boston Scientific · 17 hours ago

Design Quality Assurance Engineer III - WATCHMAN

Maple Grove, MN

Full-time

Hybrid

Mid Level

$76K/yr - $144K/yr

3+ years exp

Boston Scientific is a leader in medical science, offering an opportunity for a Design Quality Assurance Engineer III supporting WATCHMAN projects within their Cardiology division. The role involves collaborating with cross-functional teams to ensure the safety, quality, and compliance of medical device products from development through commercialization.

Health CareMedicalMedical Device

No H1B

Responsibilities

In-depth understanding and application of Design Control and Risk Management concepts. Provide quality and compliance input to project teams

Develop, update, and maintain Design History File and work with R&D for Design Input / Output documentation (Product Specification, Component Specifications, and Prints)

Develop, update, and maintain product risk management tools (i.e. Hazard Analysis, Fault Tree, FMEAs)

Support the verification, validation, and usability planning and testing to meet or exceed internal and external requirements

Work within a cross-functional team to identify and implement effective controls and support product development through commercialization

Support regulatory submissions to notified bodies

Actively participate in the Design Change process for systems to ensure the proposed changes to the products are systemically and thoroughly analyzed and assessed through the Design Control process

Apply systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues, with guidance/collaboration of the team

Qualification

Design ControlRisk ManagementISO 13485ISO 14971Quality System RegulationsMedical Device ExperienceCommunication SkillsOrganizational SkillsProblem SolvingCollaboration Skills

Required

Minimum of a Bachelors Degree in Mechanical, Electrical or Biomedical Engineering, or equivalent

Minimum of 3 years of experience in design assurance, quality, product development or related medical device or regulated industry experience

Some experience in sustaining or new product development: e.g. creating risk management deliverables (risk management plan/report, hazard analysis, task analysis, dfmea, etc.), design verification

ISO 13485, ISO 14971, and Quality System Regulations understanding

Strong communication skills (verbal & written) and presentation skills

Preferred

Focus on detailed work with emphasis on accuracy and completeness

Excellent organizational and planning skills; drives for results

High energy problem solver capable of driving items to closure

Ability to collaborate and work on a global team with peers in R&D, Process Development, Manufacturing and other groups

Experience with Class III Medical Devices

Benefits

Relocation assistance may be available for this position at this time.

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).