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Boston Scientific · 1 day ago

Principal Design Quality Engineer

Arbor Lakes, MN

Full-time

Hybrid

Senior Level, Lead/Staff

$99K/yr - $188K/yr

8+ years exp

Boston Scientific is a leader in medical science committed to solving significant health industry challenges. The Design Quality Principal Engineer will support the development of single-use devices within the Interventional Cardiology division, leading a team to apply design controls during product development.

Health CareMedicalMedical Device

No H1B

Responsibilities

Responsible for design control and risk management of next-generation medical devices

Uses clinical knowledge to influence how devices are tested and designed

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

Independently, or as a member of a team, develops, directs, and executes plans for design control and risk management of complex projects

Leads the implementation and development of product risk management tools (i.e. Hazard Analysis, Fault Tree, FMEAs)

Demonstrates good working knowledge and application of validation and statistical techniques in order to comply with associated regulatory requirements and internal standards

Adds to and promotes the culture of quality-centric patient care and customer satisfaction within the New Product Development team

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

Provides quality input (SME and/or independent reviewer) as required, at defined project/product/process milestones (e.g., design reviews, project design plans, design/process changes to existing product lines)

Keeps up to date on all ISO/EN/FDA/MDR and other Product Development-related regulatory requirements and relays this information to the Product Development group

Qualification

Design controlRisk managementISO 13485ISO 14971Quality System RegulationsMedical device experienceProblem solvingCommunication skillsOrganizational skillsTeam leadership