Senior Design Assurance Engineer

Boston Scientific•Arden Hills, MN

36d•$82,600 - $156,900•Hybrid

About The Position

This Senior Design Assurance Engineer will work on the Axonics Integration project, specifically supporting product Design Control integration under the direction of the Design Control Workstream lead. This position ensures that during the integration of products and Design Control quality system processes, the product and processes remain safe, of high quality, and compliant with BSC and regulatoryâ requirements. This Design Quality role supports the active implantable design process for both existing and new products. At Boston Scientific, we value collaboration and synergy. This role follows a hybrid work model requiring employees to be in our local office at least three days per week. In this position, you can work in Arden Hills, Maple Grove, or Minnetonka, MN, Marlborough, MA, or Irvine, CA. Relocation assistance is available for this position. Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position.

Requirements

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

Nice To Haves

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

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 regulatoryâ requirements and internal standards.
Support the verification, validation, and usability testing to meet or exceed internal and externalâ 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