- Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
- Work within a cross-functional team to identify and implement effective controls and support product development from concept through commercialization.
- Update and maintain product risk management tools (i.e. 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 or 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.
- Bachelor's degree in Mechanical Engineering, Biomedical Engineering or related field of study
- Minimum of 3 years of experience in design assurance, quality, new product development, or related medical device / regulated industry experience
- Problem solver, capable of facilitating the problem-solving process Adaptable and effective collaborator in a team environment and in self-directed work
- Strong communication skills (verbal & written)
- Demonstrated use of Quality tools/methodologies
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Quality Engineer III - Maple Grove, United States - Boston Scientific
Description
About the role:
We have an exciting opportunity for a Design Assurance (DA) Engineer III supporting WATCHMAN projects within the Interventional Cardiology division. This position supports the ongoing product performance of minimally invasive LAAC products which will provide the right candidate with excellent growth potential, commercial experience, and perspective in the medical device industry. In this position you will work a cross-functional team to support medical device field experience to assure ongoing product performance.Your responsibilities will include:
Required Qualifications:
Preferred Qualifications:
Requisition ID: 582388
Among other requirements, Boston Scientific maintains specific prohibited substance testing 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.
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.
