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Boston Scientific · 4 weeks ago

Design Quality 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, dedicated to solving significant health industry challenges. The Design Quality Engineer III will support new product development projects within the Cardiology division, ensuring compliance with design control and risk analysis throughout the product lifecycle.

Health CareMedicalMedical Device

No H1B

Responsibilities

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

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

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

Support regulatory submissions to notified bodies

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

Develop, update, and maintain the usability file: plan, participate in usability assessments, and generate/update usability documentation

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

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

Qualification

Design AssuranceRisk ManagementISO 13485ISO 14971Medical Device ExperienceCommunication SkillsOrganizational SkillsProblem-SolvingCollaboration

Required

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

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

Some experience in 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, CFRs, and Quality System Regulations understanding & demonstrated use

Excellent organizational and planning skills; drives for results

Strong communication skills (verbal & written) and presentation skills

Ability to travel up to 10%