Sr Design Quality Assurance Engineer

Recruiter: Spencer Gregory Hale

Sr Design Quality Assurance Engineer

About the role:

The Sr Design Quality Assurance Engineer will develop establish and maintain quality engineering methodologies, systems, and practices which meet BSC, customer, and regulatory requirements. The Sr Design Assurance Engineer will serve as a Quality representative to improve awareness, visibility, communication on quality initiatives to support departmental, functional, site, divisional and corporate quality goals and priorities. This Sr Design Assurance Engineer will provide focused quality engineering support within new product development, operational, or system/services support.

Your key responsibilities will include:

• Provides leadership role on championing departmental or cross-functional engineering initiatives.
• Provides project direction, coaching, and mentoring for engineering and technical team personnel.
• Proactively investigates, identifies, and implements best-in-class Quality Engineering practices.
• Mentor for technical guidance for identifying and resolving quality issues.
• Identifies and implements effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements.
• Leads in the implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal and external requirements.
• Acts as an effective leader or team member in supporting quality disciplines, decisions, and practices.
• Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• Assures the development and execution of streamlined business systems which effectively identify and resolve quality issues.

Required Qualifications:

• Minimum of a bachelor'sdegree
• Minimum of 5years of medical deviceengineering experience or other regulated industry with experience in Medical Electrical Equipment/Systems (MEE/MES)
• Understanding and practice of the FDA, ISO and the medical device industry quality requirements associated with product development, design controls, product risk management and usability engineering.
• Working knowledge of US and International regulations including any of the following: 21 CFR 820, is ideal, as well as the Medical Device Directive / Medical Device Regulation, EN ISO 13485, IEC 60601 and EN ISO 14971.
• Competent with use of Microsoft Office Suite, Minitab Statistical Analysis software (or equivalent) and/or other electrical testing/simulation software
• Travel approximately 5-10%

Preferred Qualifications:

• Masters degree preferred
• Demonstrate ability to manage and complete multiple projects and objectives and lead cross-functional teams
• Strong track record of leading and influencing without direct authority across functional groups, leadership levels and regions.
• Experience in one or more of the following areas:
• Experience in Medical Electrical Equipment/Systems (MEE / MES).
• Experience with Software as a Medical Device (SaMD) and/or systems integration
• Strong communication and presentation skills

Requisition ID:604681

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.

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 identify, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class.

Among other requirements, Boston Scientific maintains specificprohibited substancetest 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.