Principal Design Quality Engineer - Axonics Integration
Boston Scientific Gruppe, Arden Hills, MN, United States
Principal Design Quality Engineer – Axonics Integration
Onsite location: Arden Hills, MN, US, 55112
Additional locations: US-CA-Irvine; US-MA-Marlborough; US-MN-Arden Hills; US-MN-Maple Grove
Diversity - Innovation - Caring - Global Collaboration - Winning Spirit- High Performance
At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high‑performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions.
About the role: This Principal Design Quality Engineer 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. This Design Quality role supports the active implantable design process for both existing and new products.
Work Mode: This role follows a hybrid work model requiring employees to be in our local office at least three days per week. You can work in Arden Hills, Maple Grove, or Minnetonka, MN, Marlborough, MA, or Irvine, CA.
Relocation Assistance: Relocation assistance is available for this position. Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position.
Your responsibilities will include:
Apply sound, systematic problem‑solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
Act 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.
What we’re looking for in you:
Required qualifications:
Minimum of a bachelor’s degree in mechanical, electrical, or biomedical engineering (or other related technical discipline).
9+ 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.
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 qualifications:
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.
Boston Scientific Corporation is an equal opportunity employer. All employment actions are made without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, gender expression, veteran status, age, disability, genetic information, or any other protected class.
Please be advised that certain US-based positions may require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment.
This role is considered safety-sensitive and candidates will be subject to a prohibited substance test as a requirement. The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law.
Nearest major market: Minneapolis
Job Segment: Compliance, Biomedical Engineering, Quality Engineer, Risk Management, Medical Device Engineer.
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Onsite location: Arden Hills, MN, US, 55112
Additional locations: US-CA-Irvine; US-MA-Marlborough; US-MN-Arden Hills; US-MN-Maple Grove
Diversity - Innovation - Caring - Global Collaboration - Winning Spirit- High Performance
At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high‑performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions.
About the role: This Principal Design Quality Engineer 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. This Design Quality role supports the active implantable design process for both existing and new products.
Work Mode: This role follows a hybrid work model requiring employees to be in our local office at least three days per week. You can work in Arden Hills, Maple Grove, or Minnetonka, MN, Marlborough, MA, or Irvine, CA.
Relocation Assistance: Relocation assistance is available for this position. Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position.
Your responsibilities will include:
Apply sound, systematic problem‑solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
Act 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.
What we’re looking for in you:
Required qualifications:
Minimum of a bachelor’s degree in mechanical, electrical, or biomedical engineering (or other related technical discipline).
9+ 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.
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 qualifications:
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.
Boston Scientific Corporation is an equal opportunity employer. All employment actions are made without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, gender expression, veteran status, age, disability, genetic information, or any other protected class.
Please be advised that certain US-based positions may require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment.
This role is considered safety-sensitive and candidates will be subject to a prohibited substance test as a requirement. The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law.
Nearest major market: Minneapolis
Job Segment: Compliance, Biomedical Engineering, Quality Engineer, Risk Management, Medical Device Engineer.
#J-18808-Ljbffr