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Senior Design Assurance Engineer - Axonics IntegrationBoston Scientific • Arden Hills, Minnesota, United States
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Senior Design Assurance Engineer - Axonics Integration

Boston Scientific
  • US
    Arden Hills, Minnesota, United States
  • US
    Arden Hills, Minnesota, United States
Jetzt Bewerben

Über

Additional Locations US-MN-Maple Grove; US-CA-Irvine; US-MA-Marlborough; US-MN-Arden Hills About the Role 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. The 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 Model 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 is available for this position. Responsibilities 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. Required Qualifications 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 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. Compensation Minimum salary: $85,000. Maximum salary: $161,500. Actual compensation will vary based on location and other factors. Equal Opportunity Employer Statement Boston Scientific Corporation has been and will continue to be an equal opportunity employer. To ensure full implementation of its equal employment policy, the Company will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered 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. COVID-19 Vaccination and Prohibited Substance Testing For certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, 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. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination. This role is deemed safety‑sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement.
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  • Arden Hills, Minnesota, United States

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  • English
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