Senior Design Quality Engineer - Axonics Integration

Additional Location(s):  N/A; US-CA-Irvine; US-MA-Marlborough

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 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. 
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 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) 
• 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 

Requisition ID: 602812 

Minimum Salary: $ 82600 

Maximum Salary: $ 156900 

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.

As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do – as a global business and as a global corporate citizen.

So, choosing a career with Boston Scientific (NYSE: BSX) isn’t just business, it’s personal. And if you’re a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!

At Boston Scientific, we recognize that nurturing a diverse and inclusive workplace helps us be more innovative and it is important in our work of advancing science for life and improving patient health. That is why we stand for inclusion, equality, and opportunity for all. By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve. 

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 identify, 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.