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Principal Design Quality Engineer - Axonics IntegrationBoston Scientific • Minnetonka, Minnesota, United States
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Principal Design Quality Engineer - Axonics Integration

Boston Scientific
  • US
    Minnetonka, Minnesota, United States
  • US
    Minnetonka, Minnesota, United States
Jetzt Bewerben

Über

Locations Additional Locations: US-MN-Minnetonka; US-CA-Irvine; US-MA-Marlborough; US-MN-Arden Hills; US-MN-Maple Grove.
About the Role Principal Design Quality Engineer – Axonics Integration project. Supports product Design Control integration under the direction of the Design Control Workstream lead. Ensures products and processes remain safe, high‑quality, and compliant with Boston Scientific (BSC) and regulatory requirements, focusing on the active implantable design process for Urology Division.
Work Mode Hybrid: requires presence in the local office at least three days per week. Possible locations: Arden Hills, Maple Grove, Minnetonka (MN), Marlborough (MA), Irvine (CA).
Relocation Assistance Available.
Visa Sponsorship Boston Scientific will not offer or take over sponsorship of an employment visa for this position.
Your Responsibilities
Apply systematic problem‑solving methodologies to identify, prioritize, communicate, and resolve quality issues.
Act as an effective team member supporting quality disciplines, decisions, and practices.
Collaborate with cross‑functional teams to identify and implement effective controls and support integration of design‑control related products, records, and processes.
Produce technical documentation for procedure execution, technical rationale, and evidence of the development process.
Support Design Assurance activities related to risk‑management remediation, Design Control quality‑system integration, and other integration and hybridization processes.
Support post‑market activities as necessary, based on post‑market signals.
Participate in the Design Change process, ensuring proposed changes are systematically and thoroughly analyzed and assessed.
Apply validation and statistical techniques in compliance with regulatory requirements and internal standards.
Support 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, Prints).
Generate, update, and maintain product risk‑management tools (Hazard Analysis, Fault Tree, FMEA, Task Analysis).
Partner with R&D to determine and implement Design Controls based on risk management, customer needs, and manufacturing input.
Collaborate cross‑functionally to identify and support value‑improvement efforts aligned with business goals.
Required Qualifications
Bachelor’s degree in mechanical, electrical, or biomedical engineering (or other related technical discipline).
Minimum nine 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 verbal and written communication skills.
Demonstrated use of quality tools/methodologies.
Ability to effectively work and collaborate in a mixed onsite + remote environment.
Experience creating detailed technical documents.
Preferred Qualifications
Experience with medical electrical equipment and/or active implantables.
Quality integration experience.
Understanding of ISO 13485, ISO 14971, and quality‑system regulations with a focus on Design Controls and Risk Analysis.
Experienced problem solver who can facilitate 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.
Compensation Minimum: $102,100 – Maximum: $194,000.
Equal Employment Opportunity Boston Scientific Corporation is an equal‑opportunity employer. All hiring decisions are made without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class.
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  • Minnetonka, Minnesota, United States

Sprachkenntnisse

  • English
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