Design Assurance Engineer II

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:

The Design Assurance Engineer II will develop, establish and maintain quality engineering methodologies, systems, and practices which meet BSC, customer, and regulatory requirements. This 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 engineer will provide focused quality engineering support within new product development, operational, or system/services support.

 

Your Responsibilities Will Include:

• Identify and implement effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements.
• Lead 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.
• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• Assure in the development and execution of streamlined business systems which effectively identify and resolve quality issues.

 

Required Qualifications:

• Bachelor’s Degree Mechanical, Electrical or Biomedical Engineering, or equivalent.
• Minimum of 3 years of experience
• In depth familiarity with the FDA, ISO, MDD, and the medical device industry quality requirements associated with product design & development and product risk management.
• Strong communication (oral and written) and presentation skills.
• Competent with use of Microsoft Office Suite, Minitab Statistical Analysis software (or equivalent).
• Ability to collaborate and work on a global team.
• Position located in Marlborough, MA
• Travel approximately <10%

 

Preferred Qualifications:

• Detailed understanding and experience with the IEC 60601-1 Medical Electrical Equipment Standard and/or supplemental standards.
• Experience working with medical equipment systems.
• Good written and verbal communication skills. 

• Must be able to work independently under limited supervision 

 

 

 

 

Requisition ID: 612330 

Minimum Salary: $ 72800 

Maximum Salary: $ 138300 

 

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.

 

As a leader in medical science for more than 40 yea