Senior Design Assurance Engineer - Axonics Integration

Boston Scientific; Arden Hills (MN); Hybrid; USD 85,000 - 162,000; Full time

Benefits offered by this job

Relocation assistance

Hybrid work model

Office locations in Arden Hills, Maple

Office locations in Arden Hills, Maple

Minnetonka, Marlborough, Irvine

Job summary

Boston Scientific is seeking a Senior Design Assurance Engineer to support the Axonics Integration project, ensuring Design Control processes meet regulatory requirements and product safety standards. The role involves collaboration across cross-functional teams in a hybrid model with in-office presence at Arden Hills, Maple Grove, Minnetonka, Marlborough, MA, or Irvine, CA.

Relocation assistance is available, and the company emphasizes quality, risk management, and robust documentation

Qualifications

• Bachelor’s degree in mechanical, electrical, or biomedical engineering or related technical discipline.
• 5+ years of experience in design assurance or medical device development.
• Self-motivated with bias for action and strong communication.
• Ability to work in mixed onsite + remote environment.
• Experience creating detailed technical documents.

Responsibilities

• Apply systematic problem-solving to identify and resolve quality issues.
• Support quality disciplines and cross-functional decisions.
• Help integrate design control records and processes with other products.
• Write technical documentation for procedures, rationale, and development evidence.
• Support risk management remediation and design control integration.
• Support post-market activities based on signals.
• Participate in Design Change process with thorough analysis.
• Apply validation and statistical techniques per regulatory standards.
• Support verification, validation, and usability testing.
• Develop and maintain Design History File and related specifications.
• Maintain product risk management tools (Hazard Analysis, FMEAs).
• Partner with R&D to implement Design Controls.
• Collaborate cross-functionally to support value improvement.

Skills

Problem solving

Communication

Quality tools

Collaboration

Technical writing

Education

Bachelor’s degree in engineering

Job description

Additional Location(s):

US-MN-Maple Grove; US-CA-Irvine; US-MA-Marlborough; US-MN-Arden Hills

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 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 regulatoryrequirements. 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.

Your Responsibilities Will Include

• 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 regulatoryrequirements and internal standards.
• Support the verification, validation, and usability testing to meet or exceed internal and externalrequirements
• 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

What we’re looking for in you:

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

Requisition ID: 630849

Minimum Salary: $ 85000

Maximum Salary: $ 161500

The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) – see www.bscbenefitsconnect.com—will vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role. Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs. At BSC, it is not typical for an individual to be hired near the bottom or top of the anticipated salary range listed above.

Compensation for non-exempt (hourly), non-sales roles may also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).

Compensation for exempt, non-sales roles may also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).

For MA positions

It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.

Boston Scientific transforms lives through innovative medical technologies that improve the health of patients around the world. As a global medical technology leader for more than 45 years, we advance science for life by providing a broad range of high-performance solutions that address unmet patient needs and reduce the cost of healthcare. Our portfolio of devices and therapies helps physicians diagnose and treat complex cardiovascular, respiratory, digestive, oncological, neurological and urological diseases and conditions. Learn more atwww.bostonscientific.comand follow us onLinkedIn.

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.

Please be advised that 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.

Among other requirements, Boston Scientific maintains specific prohibited substance test requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, 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.