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Boston Scientific · 1 month ago

Senior Design Assurance Engineer - WATCHMAN

Maple Grove, MN

Full-time

Onsite

Mid, Senior Level

$83K/yr - $157K/yr

5+ years exp

Boston Scientific is a leader in medical science committed to solving health industry challenges. They are seeking a Senior Design Assurance Engineer to support new product development projects within the Cardiology division, focusing on maintaining design control and risk analysis throughout the product lifecycle.

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

Support the execution and documentation of Design Validation & Verification and Usability activities

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

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

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

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

Lead and support cross-functional root-cause analysis investigation and resolution activities

Support regulatory submissions to notified bodies

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 ControlRisk ManagementQuality System RegulationsNew Product DevelopmentISO 13485ISO 14971FMEAsCommunicationProblem SolvingTeam CollaborationOrganizational Skills

Required

Bachelor's degree in Mechanical Engineering, Biomedical Engineering or related Engineering field of study

Minimum of 5 years of experience in design assurance, quality, or related medical device or regulated industry experience

Experience in new product development: e.g. driving and creating risk management deliverables (risk management plan/report, hazard analysis, task analysis, dfmea, etc.), validating test methods, supporting the creation of design requirements, design verification and validation

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)

Demonstrated use of Quality tools/methodologies

Ability to travel up to 10%

Preferred

Experience in developing test methods

Experience supporting clinical trials

Problem solver, capable of facilitating the problem-solving process

Adaptable and effective collaborator in a team environment and in self-directed work

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 is available for this position at this time.

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).