Design Assurance Engineer III - Axonics Integration
About The Position
This Design Assurance Engineer III position 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 regulatory requirements. Work mode: At Boston Scientific, we value collaboration and synergy. This hybrid role is based in Arden Hills, MN and requires being on-site at least three days per week. Relocation assistance: Relocation assistance is available for this position at this time. Visa sponsorship: Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time.
Requirements
- Minimum of a bachelor’s degree in mechanical, electrical, or biomedical engineering (or other related technical discipline)
- 3+ 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
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 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
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Mid Level
