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Senior Design Quality Engineer
3 months ago
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 Design Quality Engineer supporting WATCHMAN projects within the Interventional Cardiology division. This position supports a major product category with high visibility which will provide the right candidate with excellent growth potential, commercial experience, and perspective in the medical device industry. The Senior Design Quality Engineer will work with a high-performance cross-functional team to ensure safety, quality and compliance of WATCHMAN products to deliver the highest quality product to the customer.
Your responsibilities include:
- Functional lead who applies sound, systematic problem-solving methodologies in identifying, analyzing, prioritizing, communicating, and resolving quality issues.
- Facilitate cross-functional team to identify/implement effective controls and support product performance/development.
- Demonstrates sound working knowledge and application of risk management file.
- Assess, maintain, and update product trending (e.g. Risk Thresholds) and evaluate associated product risk management impact (e.g. Hazard Analysis, Fault Tree, FMEAs).
- Demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
- Mentor for technical guidance for identifying and resolving quality issues.
- Acts as an effective leader/team member in supporting quality disciplines, decisions, and practices.
- Support submissions to notified bodies.
- Assures the development and execution of streamlined business systems which effectively identify and resolve quality issues.
- Mentor cross functional team through product life cycle process; specifically, with respect to design control and risk management deliverables.
Minimum qualifications:
- Bachelor's degree in Biomedical Engineering, Mechanical Engineering or related field of study
- 5+ years' experience in Design Quality or related medical device experience; or Master's degree and 3 years' experience
- Hands-on approach to product development
- Demonstrated use of Quality tools/methodologies
- ISO 13485, ISO 14971, and Quality System Regulations understanding with a focus on Design Controls and Risk Analysis
Preferred qualifications:
- Self-motivated with a passion for solving problems and a bias for action
- Ability to manage multiple priorities and work with ambiguity
- Strong communication skills (verbal & written)
Requisition ID:588230
Among other requirements, Boston Scientific maintains specific prohibited substancetesting requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a drug test as a pre-employment requirement. The goal of the drug testing is to increase workplace safety in compliance with the applicable law.
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 is proud to be an equal opportunity and affirmative action employer.
Boston Scientific maintains a prohibited substance free workplace. Pursuant to Va. Code * , Boston Scientific is providing notification that the unlawful manufacture, sale, distribution, dispensation, possession, or use of a controlled substance or marijuana is prohibited in the workplace and that violations will result in disciplinary action up to and including termination.
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.
Boston Scientific is an Equal Opportunity Employer – Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Disability, Veteran
