Principal Design Quality Engineer - Cardiology

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:

This Principal Design Quality Engineer position will support active implantable medical devices. This position collaborates with cross functional teams including R&D, process development, manufacturing, and regulatory affairs to help ensure that the product and processes remain safe, of high quality, and compliant with BSC and regulatory requirements throughout the product lifecycle process.

Work Mode:

Boston Scientific values collaboration, and this hybrid role requires employees to work from the Arden Hills, MN office at least three days per week.

Relocation Assistance:

Relocation assistance is not available for this position.

Visa Sponsorship:

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

Your responsibilities will include:

* Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.

* Acts as an effective team member in supporting quality disciplines, decisions, and practices.

* Work within a cross-functional team to identify and implement effective controls for new technology in complex medical devices.

* Write various technical documentation for procedure execution, technical rationale, and evidence of the development process.

* Support Design Assurance activities as related to Risk Management, Design Controls, and other DA related priorities.

* Support Post Market activities, as necessary, of risk based on post-market signals.

* Actively participate in the Design Change process to ensure the proposed changes to the products are systemically and thoroughly analyzed and assessed.

* Demonstrate good working knowledge and application of validation and statistical techniques in compliance with associated regulatory requirements and internal standards.

* Support the verification, validation, and usability testing to meet or exceed internal and external requirements.

* Develop, update, and maintain Design History File and Design Input / Output documentation (Product Specification, Component Specifications, and Prints).

* Generate, update, and maintain product risk management tools (e.g., Hazard Analysis, Fault Tree, FMEAs).

* Partner with R&D to determine and implement Design Controls based on Risk Management, Customer Needs, and Manufacturing Input.

* Partner cross-functionally to identify and support value improvement efforts to support business goals.

What we're looking for in you:

Required qualifications:

* Minimum of a bachelor's degree in mechanical, electrical, or biomedical engineering (or other related technical discipline).

* 9+ years of experience in design assurance, new product development or related medical device / regulated industry experience.

* Self-motivated with a passion for solving problems and a bias for action.

* Strong communication skills (verbal & written).

* Demonstrated use of Quality tools/methodologies.

* Ability to effectively work and collaborate in a mixed onsite + remote environment.

* Demonstrated experience creating detailed technical documents.

Preferred qualifications:

* Experience working with medical electrical equipment and/or active implantables.

* ISO 13485, ISO 14971 and Quality System Regulations understanding with a focus on Design Controls and Risk Analysis.

* Experienced problem solver, capable of facilitating the problem-solving process.

* Adaptable and effective collaborator in a team environment or in self-directed work.

* Experience with design changes, complaint reduction, and corrective action.

Requisition

Minimum Salary: $ 102100

Maximum Salary: $ 194000

The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) - see  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…