Senior Design Quality Engineer - Bolt Integration

About the role: The Senior Design Quality Engineer provides support with high visibility which will provide the right candidate with excellent growth potential.Work with high-performance cross-functional sustaining team to ensure safety, quality and compliance of launched products while continuously improving their commercial value through end-of-life. The role would be supporting SEISMIQ console sustainment manufactured at Arden Hills and Carlsbad site. The Senior Design Quality Engineer works in close partnership with Research and Development and supporting functions (supplier engineering, operations, regulatory, post market) focuses on protecting the design intent of a product to meet safety, efficacy, regulatory, and business requirements. May mentor less experienced Quality staff, as well as other cross-functional stakeholders on implementing Quality processes and procedures as appropriate., * Acts as an effective leader or team member in supporting quality disciplines, decisions, and practices.

• Applies experienced technical quality engineering principles to assigned products or sites and guides them into implementation.

• Provides project direction, coaching, and mentoring for engineering and technical team personnel.

• Advise management on potential improvements or enhancement to quality systems and processes in the company.

• Provides support and guidance to team members

• Proactively investigates, identifies, and implements best-in-class Design Quality Engineering practices.

• Actively participate in the Design Change process for systems to ensure the proposed changes to the products are systemically and thoroughly analyzed and assessed through the Design Control process.

• Partner with R&D, manufacturing, supplier team and cross-site teams to determine and implement Design Controls based on Risk Management, Customer Needs, and Manufacturing Input.

• Applies systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues, which may include NCEP and CAPA ownership, core team member and coordination

• Monitor field performance of recently launched and established medical devices against risk assessments

• Actively participate on Risk Change assessment process: generate, update, and maintain product risk management tools (i.e. Hazard Analysis, Fault Tree, FMEAs).

• Support the verification, validation, and usability testing to meet or exceed internal and external requirements

• Interact with software changes for alignment with system level design impact assessments.

• Develop, update, and maintain Design History File and work with RD for Design Input / Output documentation (Product Specification, Component Specifications, and Prints)

• Bachelor's degree in chemical, medical engineering, science, mechanical, electrical, computer engineering, or related discipline
• 5+ years experience in design assurance, new product development, or related medical device / regulated industry experience
• Working knowledge of US and International regulations including 21 CFR 820, Medical Device Directive / Medical Device Regulation, EN ISO 13485, and EN ISO 14971
• Strong communication skills (verbal & written)
• Demonstrated use of Quality tools/methodologies.
• Ability to effectively work and collaborate in a cross-site environment.

Preferred qualifications:

• Experience with medical electrical systems / electrical medical equipment / capital equipment and software (inclusive of IEC 62304)
• Previous development of medical device system experience
• 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 risks, and corrective action
• Acquisition experience with cross-site collaboration

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 byprovidinga 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,neurologicaland 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 specificprohibited substancetest 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.