Design Assurance Engineer III - Electrophysiology

About the role

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.

Work Mode

We value collaboration and synergy. This role follows a hybrid work model requiring employees to be in our local office three days per week.

Relocation assistance
Relocation assistance is not available for this position at this time.

Visa sponsorship
Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time.

• Work cross-functionally with R&D, project management, manufacturing, regulatory, clinical and marketing to ensure project success.
• Lead/support the determination and implementation of Design Controls based on Risk Management, Customer Needs, and Manufacturing Input.
• Maintain product risk management documentation (i.e. Hazard Analysis & FMEAs).
• Lead/support the development of and coordinate the execution and documentation of Design Validation and Verification activities.
• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• Support and lead the execution and investigation of CAPAs, NCEP, Complaints, Failure Mode Investigations, etc.
• Demonstrate good working knowledge and application of validation and statistical techniques to comply with associated regulatory requirements and internal standards.
• Able to navigate gray space by applying risk-based criteria to prioritize project work.
• Support cross functional team through product life cycle process; specifically, with respect to design control and risk management deliverables.

• Minimum of a bachelor's degree in Materials, Mechanical, Electrical, Chemical, Biotechnology, Electromechanical or related field of study
• Minimum 4 years of experience in Quality Assurance and/or Design Assurance, Sustaining, R&D, Manufacturing or related medical device experience
• ISO 13485, ISO 14971, and Quality System Regulations understanding with a focus on Design Controls and Risk Analysis
• Experience navigating design, manufacturing and/or supplier variations

• Strong understanding of NCEP/CAPA processes
• Previous experience working to create/maintain risk documentation such as FMEAs and HAs
• Experience working with Stature or FMEA MED-8 software
• 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)
• Proficiency in collaborating with interdisciplinary teams
• Familiar with EP environment

Requisition : 623790

Salary range: Minimum $82,100;
Maximum $156,000

The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific will vary based on actual location 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., 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 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 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…