Design Quality Engineer II

Valencia, CA - USA

Monthly Salary: Not Disclosed

Posted on: 2 hours ago

Vacancies: 1 Vacancy

Job Summary

Additional Location(s):US-CA-Valencia; Canada-ON-Mississauga; US-IN-Spencer; US-MA-Marlborough; US-MA-Waltham; US-MN-Maple Grove

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit- High Performance

At Boston Scientific well give you the opportunity to harness all thats 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 well help you in advancing your skills and career. Here youll be supported in progressing whatever your ambitions.

About the role:

This position will work on the EP/CRM Integration projects specifically supporting Design Controls 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 regulatory requirements. The Design Quality Engineer II directly supports medical device product development from concept through commercialization.

Work Mode:

This role follows a hybrid work model requiring employees to be in our local office at least three days per week. Candidates can be based out of the following locations: Arden Hills Maple Grove Valencia Waltham Marlborough Spencer or Mississsauga

Visa Sponsorship:
Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time.

Relocation:

This role will not provide relocation support or assistance.

Your responsibilities will include:

Apply sound systematic problem-solving methodologies in identifying prioritizing communicating and resolving quality issues.
Work within a cross-functional team to identify and implement effective controls and support integration of design control related products records and processes

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)

Support Design Assurance (DA) activities as related to Design Control Quality System integration and other DA related integration priorities
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 bachelors degree in mechanical electrical or biomedical engineering (or other related technical discipline)

Minimum of 2 years of experience in Quality design assurance new product development or related medical device/regulated industry experience
Ability to travel up to 10%

Preferred qualifications:

Quality Integration experience

ISO 13485 ISO 14971 and Quality System Regulations understanding with a focus on Design Controls and Risk Analysis

Boston Scientific experience
Ability to effectively work and collaborate in a mixed onsite remote environment.

Requisition ID:620941

Minimum Salary: $71500

Maximum Salary: $ 135800

The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) see 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 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.

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.

Required Experience:

Additional Location(s):US-CA-Valencia; Canada-ON-Mississauga; US-IN-Spencer; US-MA-Marlborough; US-MA-Waltham; US-MN-Maple GroveDiversity - Innovation - Caring - Global Collaboration - Winning Spirit- High PerformanceAt Boston Scientific well give you the opportunity to harness all thats within you ...