Design Quality Assurance Engineer II, Renal Denervation at Boston Scientific Corporation Malaysia

Maple Grove, Minnesota, United States -

Full Time

Start Date

Immediate

Expiry Date

29 Jan, 26

Salary

132000.0

Posted On

31 Oct, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Design Assurance, Quality Engineering, ISO 13485, ISO 14971, Risk Management, Problem Solving, Communication Skills, Usability Testing, Regulatory Submissions, Collaboration, Product Development, Verification, Validation, Documentation, Clinical Products, Medical Devices

Industry

Medical Equipment Manufacturing

Description

Additional Location(s): N/A 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 is an exciting opportunity for a Design Quality Assurance Engineer II to join a cross-functional team on the new Renal Denervation business within BSC's Cardiology division. This position will support the significant new Renal Denervation acquisition integration and product development programs with high visibility, which will provide the right candidate with excellent growth potential, acquisition integration experience, and broad perspective in the medical device industry. The engineer will provide quality engineering support to acquisition integration, product development and sustaining projects for current clinical products and future commercial products. They will develop, establish, and maintain quality-engineering methodologies, systems, and practices which meet BSC, customer, and regulatory requirements. The Design Quality Engineer II will serve as a Quality representative to improve awareness, visibility, and communication on quality initiatives to support assigned departmental, functional, site, divisional and corporate quality goals. At Boston Scientific, we value collaboration and synergy. This role requires employees to be in our Arbor Lakes office four days per week. Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time. Your responsibilities will include: Support the verification, validation, and usability planning and testing to meet or exceed internal and external requirements Develop, update, and maintain Design History File and work with R&D for Design Input / Output documentation (Product Specification, Component Specifications, and Prints) Work within a cross-functional team to identify and implement effective controls and support product development through commercialization. Support regulatory submissions to notified bodies. Develop, update, and maintain product and/or software risk management tools (i.e. Hazard Analysis, Fault Tree, FMEAs) Develop, update, and maintain the usability file: plan, participate in usability assessments, and generate/update usability documentation Apply systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues, with guidance/collaboration of the team Required qualifications: Bachelors Degree in Engineering (preferably in Mechanical, Electrical or Biomedical) or related degree. Minimum of 3 years of experience in design assurance, quality, or related regulated industry experience Self-motivated with a passion for solving problems and a bias for action. ISO 13485/ Quality System Regulations, ISO 14971/Risk Management understanding Strong communication skills (verbal & written) and presentation skills Preferred qualifications: Medical Electrical Equipment, Cybersecurity and Software design controls understanding Focus on detailed work with emphasis on accuracy and completeness Excellent organizational and planning skills; drives for results High energy problem solver capable of driving items to closure Ability to collaborate and work on a global team with peers in R&D, Process Development, Manufacturing and other groups. Requisition ID: 614227 Minimum Salary: $ 69500 Maximum Salary: $ 132000 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 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.

Responsibilities

The Design Quality Assurance Engineer II will support verification, validation, and usability planning and testing for product development and acquisition integration. They will also develop and maintain quality engineering methodologies and documentation to meet regulatory requirements.