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Boston Scientific · 1 month ago

Senior Design Assurance Engineer

Arden Hills, 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 important health industry challenges. The Senior Design Assurance Engineer will support product Design Control integration, ensuring product safety, quality, and compliance with regulatory requirements while working within cross-functional teams.

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 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

Write various technical documentation for procedure execution, technical rationale, and evidence of the development process

Support Design Assurance activities as related to Risk Management remediation, Design Control Quality System integration, and other DA related integration priorities

Support Post Market activities, as necessary, of risk based on post-market signals

Actively participate in the Design Change process to ensure the proposed changes to the products are systemically and thoroughly analyzed and assessed

Demonstrate good working knowledge and application of validation and statistical techniques in compliance with associated regulatory requirements and internal standards

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)

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

Design AssuranceRisk ManagementQuality System RegulationsStatistical TechniquesISO 13485ISO 14971Technical DocumentationProblem SolvingCollaborationCommunication SkillsAdaptability

Required

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

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

Self-motivated with a passion for solving problems and a bias for action

Strong communication skills (verbal & written)

Demonstrated use of Quality tools/methodologies

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

Demonstrated experience creating detailed technical documents

Preferred

Experience working with medical electrical equipment and/or active implantables

Quality Integration experience

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

Experienced problem solver, capable of facilitating the problem-solving process

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

Experience with design changes, complaint reduction, and corrective action

Benefits

Relocation assistance is available for this position.

Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs.

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).