Senior Design Quality Engineer - Bolt Integration

Additional Locations: US-MN-Maple Grove; US-MN-Arden Hills

The Senior Design Quality Engineer provides support with high visibility, offering excellent growth potential. The role works with a 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. Support is focused on SEISMIQ console sustainment manufactured at Arden Hills and Carlsbad site. The engineer works closely with Research and Development and supporting functions (supplier engineering, operations, regulatory, post‑market) to protect the design intent of a product to meet safety, efficacy, regulatory, and business requirements.

The engineer may mentor less experienced quality staff and other cross‑functional stakeholders on implementing quality processes and procedures as appropriate.

Hybrid role based at the Arbor Lakes Campus in Maple Grove, MN, requiring on‑site presence at least three days per week. Candidates based in Arden Hills, MN, may also be considered.

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.
• Provides support and guidance to team members.
• Proactively investigates, identifies, and implements best‑in‑class Design Quality Engineering practices.
• Actively participates 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.
• Partners 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, including NCEP and CAPA ownership, core team member coordination.
• Monitors field performance of recently launched and established medical devices against risk assessments.
• Participates in Risk Change assessment process: generates, updates, and maintains product risk management tools (e.g., Hazard Analysis, Fault Tree, FMEAs).
• Supports verification, validation, and usability testing to meet or exceed internal and external requirements.
• Integrates software changes for alignment with system‑level design impact assessments.
• Develops, updates, and maintains Design History File and works 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 of experience in design assurance, new product development, or related medical device / regulated industry experience.
• Knowledge of US and international regulations including 21 CFR 820, Medical Device Directive / Medical Device Regulation, EN ISO 13485, and EN ISO 14971.
• Strong verbal and written communication skills.
• Proficiency with quality tools and methodologies.
• Capability 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).
• Experience in development of medical device systems.
• Problem‑solving aptitude, capable of facilitating the process.
• Collaborative self‑directed work style.
• Experience with design changes, complaint risks, and corrective action.
• Acquisition experience with cross‑site collaboration.