Senior Design Quality Engineer - Bolt Integration

The Senior Design Quality Engineer provides support with high visibility which will provide the right candidate with excellent growth potential. Work with high-performance cross-functional sustaining team to ensure safety, quality and compliance of launched products while continuously improving their commercial value through end-of-life.

The role would be supporting SEISMIQ console sustainment manufactured at Arden Hills and Carlsbad site. The Senior Design Quality Engineer works in close partnership with Research and Development and supporting functions (supplier engineering, operations, regulatory, post market) focuses on protecting the design intent of a product to meet safety, efficacy, regulatory, and business requirements.

May mentor less experienced Quality staff, as well as other cross-functional stakeholders on implementing Quality processes and procedures as appropriate.

At Boston Scientific, we value collaboration and synergy. This hybrid role is based at the Arbor Lakes Campus in Maple Grove, MN and requires being on-site at least three days per week. We will also consider candidates based in Arden Hills, MN.

Relocation assistance may be available for this position at this time.

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

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

* Applies experienced technical quality engineering principles to assigned products or sites and guides them into implementation.

* Provides project direction, coaching, and mentoring for engineering and technical team personnel.

* Advise management on potential improvements or enhancement to quality systems and processes in the company.

* Proactively investigates, identifies, and implements best-in-class Design Quality Engineering practices.

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

* Partner with R&D, manufacturing, supplier team and cross-site teams to determine and implement Design Controls based on Risk Management, Customer Needs, and Manufacturing Input.

* Applies systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues, which may include NCEP and CAPA ownership, core team member and coordination

* Monitor field performance of recently launched and established medical devices against risk assessments

* Actively participate on Risk Change assessment process: generate, update, and maintain product risk management tools (i.e. Hazard Analysis, Fault Tree, FMEAs).

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

* Interact with software changes for alignment with system level design impact assessments.

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

* Bachelor's degree in chemical, medical engineering, science, mechanical, electrical, computer engineering, or related discipline

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

* Working knowledge of US and International regulations including 21 CFR 820, Medical Device Directive / Medical Device Regulation, EN ISO 13485, and EN ISO 14971

* Ability to effectively work and collaborate in a cross-site environment.

* Experience with medical electrical systems / electrical medical equipment / capital equipment and software (inclusive of IEC 62304)

* 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 risks, and corrective action