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Boston Scientific · 1 day ago

Design Quality Engineer III

Arden Hills, MN

Full-time

Hybrid

Mid Level

$78K/yr - $149K/yr

3+ years exp

Boston Scientific is a global leader in the health industry, dedicated to tackling important health challenges. The Design Quality Engineer III will support Design Controls for EP/CRM Integration projects, ensuring product quality and compliance throughout the medical device development process.

Health CareMedicalMedical Device

No H1B

Responsibilities

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

Acts as an effective team member and mentor in supporting quality disciplines, decisions, and practices

Work within a cross-functional team to identify and implement effective controls and support integration of design control related products, records, and processes

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

Develop, update, and maintain Design History File and Design Input / Output documentation (Product Specification, Component Specifications, and Prints)

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

Support Design Assurance (DA) activities as related to Design Control Quality System integration, and other DA related integration priorities

Partner with R&D to determine and implement Design Controls based on Risk Management, Customer Needs, and Manufacturing Input

Partner cross-functionally to identify and support value improvement efforts to support business goals

Qualification

Quality design assuranceDesign ControlsRisk ManagementISO 13485ISO 14971Quality System RegulationsMechanical engineeringElectrical engineeringBiomedical engineeringInfluencing without authorityCollaborationProblem-solving

Required

Minimum of a bachelor's degree in mechanical, electrical, or biomedical engineering (or other related technical discipline)

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

Ability to travel up to 10%

Preferred

Quality Integration experience

ISO 13485, ISO 14971 and Quality System Regulations understanding with a focus on Design Controls and Risk Analysis

Boston Scientific experience

Proven ability to influence without authority

Ability to effectively work and collaborate in a mixed onsite + remote environment

Benefits

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