Senior Design Quality Engineer - Bolt Integration

Boston Scientific; Arden Hills (MN); Hybrid; USD 110,000 - 160,000; Full time

Job summary

Boston Scientific is seeking a Senior Design Quality Engineer to ensure safety, quality, and compliance of launched products while improving their commercial value through end‑of‑life activities. You will work with R&D, manufacturing, supplier teams, and cross‑site partners to protect design intent and meet regulatory and business requirements.

The role requires mentoring capabilities and expertise in implementing quality processes, with on‑site presence at least three days per week in

Qualifications

• Bachelor's degree in engineering or related discipline.
• 5+ years of design assurance, new product development, or related medical device/regulated industry experience.
• Working knowledge of 21 CFR 820, Medical Device Directive/Regulation, EN ISO 13485, and EN ISO 14971.
• Strong communication skills (verbal & written).
• Demonstrated use of Quality tools/methodologies.

Responsibilities

• Acts as an effective leader or team member in supporting quality disciplines and practices.
• Applies experienced quality engineering principles to assigned products or sites and guides them into implementation.
• Provides project direction, coaching, and mentoring for engineering and technical staff.
• Advise management on potential improvements to quality systems and processes.
• Proactively investigates, identifies, and executes best‑in‑class Design Quality Engineering practices.
• Participates in the Design Change process to ensure thorough analysis and assessment through Design Control.
• Partners with R&D, manufacturing, supplier teams and cross‑site teams to determine and implement Design Controls.

Skills

Communication skills

Quality tools

Cross-site collaboration

Regulatory knowledge

Problem solving

Education

Bachelor's degree in engineering or related field

Tools

CAPA

FMEA

Hazard Analysis

Job description

Senior Design Quality Engineer

Additional Location(s): US-MN-Maple Grove; US-MN-Arden Hills

About the role

The Senior Design Quality Engineer provides support with high visibility and offers excellent growth potential. Working with a high-performance cross‑functional sustaining team, the engineer ensures safety, quality and compliance of launched products while continuously improving their commercial value through end‑of‑life. The role supports SEISMIQ console sustainment manufactured at Arden Hills and Carlsbad sites, and works in close partnership with Research and Development and supporting functions (supplier engineering, operations, regulatory, post‑market) to protect the design intent of a product and meet safety, efficacy, regulatory, and business requirements. The engineer may mentor less experienced Quality staff and cross‑functional stakeholders on implementing Quality processes and procedures as appropriate.

Work mode

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

Relocation assistance may be 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.

Responsibilities

• 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 enhancements to quality systems and processes in the company.
• Provides support and guidance to team members.
• Proactively investigates, identifies, and executes best‑in‑class Design Quality Engineering practices.
• Actively participates in the Design Change process for systems to ensure 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.
• Monitors field performance of recently launched and established medical devices against risk assessments.
• Actively participates in the Risk Change assessment process: generates, updates, and maintains product risk management tools (i.e., Hazard Analysis, Fault Tree, FMEAs).
• Supports verification, validation, and usability testing to meet or exceed internal and external requirements.
• Interacts with software changes for alignment with system level design impact assessments.
• Develops, updates, and maintains Design History File and works with R&D for Design Input / Output documentation (Product Specification, Component Specifications, and Prints).

Required Qualifications

• 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.
• Strong communication skills (verbal & written).
• Demonstrated use of Quality tools/methodologies.
• Ability to effectively work and collaborate in a cross‑site environment.

Preferred Qualifications

• Experience with medical electrical systems / electrical medical equipment / capital equipment and software (inclusive of IEC 62304).
• Previous development of medical device system experience.
• 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.
• Acquisition experience with cross‑site collaboration.

Employment Requirements

For positions requiring safe‑sensitive responsibilities, a prohibited substance test is required.

Certain US‑based positions (including, but not limited to, field sales and service positions that call on hospitals and/or health care centers) require acceptable proof of COVID‑19 vaccination status. Candidates will be notified during the interview and selection process if proof of vaccination is required. Boston Scientific will comply with all applicable state and federal law and healthcare credentialing requirements.

Equal Employment Opportunity

Boston Scientific Corporation has been and will continue to be an equal opportunity employer. To ensure full implementation of its equal employment policy, the Company will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, gender expression, veteran status, age, mental or physical disability, genetic information, or any other protected class.