Boston Scientific Principal Design Assurance Engineer 

United States, Minnesota, Minnetonka 

589720081

The Principal Design Assurance Engineer will develop establish and maintain quality engineering methodologies, systems, and practices which meet BSC, customer, and regulatory requirements. The Principal 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 Principal 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 Bachelors degree
• Minimum of 7 years of medical device engineering 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

Maximum Salary: $ 188300

Compensation fornon-exempt (hourly), non-sales rolesmay 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 forexempt, non-sales rolesmay 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.

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.