Senior R&D Engineer - Sustaining at Boston Scientific Corporation Malaysia

Maple Grove, Minnesota, United States -

Full Time

Start Date

Immediate

Expiry Date

23 Feb, 26

Salary

156900.0

Posted On

25 Nov, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Electrical Engineering, Mechanical Engineering, Biomedical Engineering, Medical Device Design, Sustaining Engineering, Communication Skills, Presentation Skills, Problem-Solving Skills, Documentation Control, Non-Conformance, CAPA, Altium, SolidWorks, Regulatory Compliance, Quality Systems, Cross-Functional Collaboration

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: We have an exciting opportunity for a Senior R&D Engineer focusing on Sustaining activities. This is a unique opportunity to work on cutting-edge technology and make a significant impact on patient care and clinical outcomes within the Interventional Cardiology division here at Boston Scientific. Work Mode: At Boston Scientific, we value collaboration and synergy. This role follows a hybrid work model, requiring employees to be in our Maple Grove, MN office at least three days per week. Your responsibilities will include: Lead Sustaining activities such as Design Change Analyses (DCA's) for Capital Equipment (i.e. - console, cart, electrical, mechanical, software, and firmware). Learn both BSC and Bolt quality systems and work with the acquisition integration team to assess when and how to design changes such that compliance is always maintained. Collaborate with cross-functional teams, including R&D, Quality, Regulatory, Operations, Supplier Engineering, Sourcing, Supply Chain, Labeling, Packaging, and others as necessary to facilitate design changes. Ensure compliance with relevant medical device regulations and standards, including IEC 60601-1, 60601-1-2, and other applicable safety standards. Create and maintain detailed technical documentation, including DCA's, BOM structures, Design Outputs, protocols, reports, and other applicable documents that will be stored in Windchill. Train and/or provide work directions to Technicians, Interns, and other Engineers as necessary (will involve hiring additional Sustaining engineers in the coming years). Provide clear and effective communication to stakeholders, including senior leadership, regarding project status, risks, and mitigation strategies. Present technical findings and recommendations at cross-functional meetings and persuade stakeholders to agree on proposed approaches. Drive organizational collaboration, helping make impactful decisions that drive organizational success within both BSC and Bolt Medical throughout the acquisition process. Applying business and industry best practices and knowledge of internal/external business challenges to improve products, processes, or services. In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to all documented quality processes and procedures. Required qualifications: Bachelor's or master's degree in electrical engineering, Mechanical Engineering, Biomedical Engineering, or a related field. Minimum of 5 years of experience in R&D, with a focus on medical device design. Previous medical device Sustaining Engineering experience needed (we are looking for someone to lead this effort - i.e. “Self-Starter”). Strong communication and presentation skills, with the ability to convey complex technical concepts to non-technical stakeholders. Preferred qualifications: Previous documentation control (e.g. - Windchill), along with Non-Conformance (NCEP) and CAPA experience. Previous medical device integration and acquisition experience (or similarly regulated field) is a major plus. Altium and SolidWorks experience would be very useful. Strong technical background in medical electrical projects, including architectural design and compliance with medical safety standards like IEC 60601-1 and IEC 60601-1-2. Excellent problem-solving skills and the ability to make data-driven decisions. Requisition ID: 618933 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 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

Lead Sustaining activities such as Design Change Analyses for Capital Equipment and ensure compliance with medical device regulations. Collaborate with cross-functional teams to facilitate design changes and maintain detailed technical documentation.