Design Quality Engineer III at Boston Scientific Corporation Malaysia

Maple Grove, Minnesota, United States -

Full Time

Start Date

Immediate

Expiry Date

09 Mar, 26

Salary

144400.0

Posted On

09 Dec, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Design Controls, Risk Management, Usability, Statistical Analysis, Root Cause Analysis, Quality Management Systems, Problem-Solving, Collaboration, Communication, Post Market Surveillance, EU MDR, IEC 62366-1, Mechanical Engineering, Biomedical Engineering, Regulatory Compliance, Quality Engineering

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: Boston Scientific Peripheral Interventions is seeking a Design Quality Engineer III to help advance our product portfolio. In this role, you will collaborate across functions to ensure device safety, quality, and regulatory compliance, delivering exceptional products to our customers. As a key member of the Quality team, you will support the design and development of a next-generation mechanical thrombectomy device within the AngioJet product family. You will apply robust quality engineering methodologies that align with Boston Scientific, customer, and regulatory standards. At Boston Scientific, we value collaboration and synergy. This role follows a hybrid work model requiring employees to be in our Maple Grove office three days per week. Relocation assistance may be 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: Be a part of extended project team to identify and implement effective controls to support development or maintenance of products to meet internal and external requirements. Develops understanding of Design Controls, Risk Management and Usability for Medical Devices. Supports departmental, functional, and divisional Design Quality goals and priorities. Executes methodologies to effectively meet individual and team objectives. Execute methodologies such as Statistical Analysis, Risk Management, and Root Cause Analysis in support of project activities. Ensure adherence to the quality systems and Design Assurance SOPs and Boston Scientific's Product Life Cycle Process (PLCP). Apply critical thinking and engineering analysis to solve problems. What we're looking for in you: Required qualifications: Bachelor of Science in Mechanical / Biomedical Engineering or related discipline. 3+ years experience in design assurance or related field, or a combination of education and experience to perform at this level. Knowledge of key regulatory requirements, including ISO 14791 (Risk Management), 21 CFR 820 (US QS Regulation), ISO 13485 (Quality Management Systems). Ability to travel up to 10%. Preferred qualifications: Understanding of Quality tools and methodologies with an emphasis on Design Controls and Risk Management. Working knowledge and application of validation and statistical techniques to comply with associated regulatory requirements and internal standards. Strong technical knowledge, problem-solving abilities, collaborative mindset, and effective communication skills. Experience with Post Market Surveillance, EU MDR, and IEC 62366-1 (Usability). Ability to work independently and as part of a team. Requisition ID: 619233 Minimum Salary: $ 76000 Maximum Salary: $ 144400 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 Engineer III will collaborate across functions to ensure device safety, quality, and regulatory compliance while supporting the design and development of a next-generation mechanical thrombectomy device. Responsibilities include identifying and implementing effective controls and executing methodologies to meet quality system requirements.