Senior Design Quality Assurance Engineer at Boston Scientific Corporation Malaysia

Georgetown, Massachusetts, United States -

Full Time

Start Date

Immediate

Expiry Date

17 Feb, 26

Salary

164500.0

Posted On

19 Nov, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Biomedical Engineering, Mechanical Engineering, Medical Device Engineering, Regulatory Requirements, Statistical Analysis, Design Controls, Quality Engineering, Risk Management, Technical Problem-Solving, Communication Skills, Interpersonal Skills, Leadership, Mentoring, Strategic Mindset

Industry

Medical Equipment Manufacturing

Description

Your responsibilities will include: Ensure compliance with ISO 14971 and demonstrate a strong commitment to patient safety. ● Bachelor's degree in Biomedical Engineering, Mechanical Engineering, or a related field. ● Minimum of 5 years' experience in medical device engineering. ● Detailed understanding of U.S. and international regulatory requirements including 21 CFR Part 820, MDD/EU MDR, ISO 13485, and ISO 14971. ● Minimum of 6 years' experience in medical device engineering. ● Proficiency with Minitab or equivalent statistical analysis software. ● Strong expertise in design controls, quality engineering, risk management, and technical problem-solving. ● Excellent communication and interpersonal skills with proven ability to influence teams and leadership. ● Demonstrated leadership and mentoring capabilities in a quality-driven environment. ● Strategic mindset with the ability to manage hands-on project needs and long-term initiatives. LI-Hybrid Requisition ID: 617814 Minimum Salary: $ 86600 Maximum Salary: $ 164500 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. 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! 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. 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. 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. 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

Ensure compliance with ISO 14971 and demonstrate a strong commitment to patient safety. Manage hands-on project needs and long-term initiatives in a quality-driven environment.