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Boston Scientific · 1 month ago

Senior Design Quality Engineer

Maple Grove, MN

Full-time

Hybrid

Mid, Senior Level

$83K/yr - $157K/yr

5+ years exp

Boston Scientific is a leader in medical science committed to solving health industry challenges. The Senior Design Quality Engineer will provide quality engineering leadership on new product development design assurance, driving risk management and verification & validation processes for electronic medical equipment in the Interventional Cardiology/Vascular division.

Health CareMedicalMedical Device

No H1B

Responsibilities

Lead or mentors the project team in the execution of deliverables such as Design and Development Planning, Risk Management, Design Verification and Validation, Usability Validation plans, Design Review, Field Assessment, Design Change, and NCEP/CAPA/PIR

Effectively communicates within project team, across functions, and elevates issues above the project team as appropriate

Develops solutions to complex and diverse technical problems which require the regular use of ingenuity and creativity. Analysis of situations or data requires an in-depth evaluation of various factors

Influences cross-functional plans, guides overall project strategy, knows when to solicit feedback, and facilitate project decisions

Builds quality into all aspects of work by maintaining compliance to all quality requirements, defending work of their team, as well as supports internal external regulatory audits

Participates as a division representative in cross-divisional projects defining the quality system and may advise management on potential improvements to the quality systems and processes

Supports functional and divisional design quality goals and priorities

Qualification

Design AssuranceRisk ManagementVerification & ValidationQuality Tools/MethodologiesElectrical Safety StandardsReliability TestingQSRISO StandardsMedical Device ExperienceASQ CertificationCommunication SkillsTeam CollaborationProblem SolvingMentoring

Required

Bachelor's degree in mechanical, electrical, biomedical engineering, or related discipline

5+ years of related experience in design assurance, new product development, or related medical device or regulated industry experience

Understanding of electrical safety standards IEC 60601

Experience with reliability testing

Demonstrated use of Quality tools/methodologies

Strong written/verbal communication skills

Preferred

Experience with class III medical devices

BS in Electrical Engineering

Previous R&D experience

Strong knowledge of QSR and ISO standards

Medical device experience

ASQ certification

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).