Principal Design Quality Engineer - Product Development

Position: Principal Design Quality Engineer - New Product Development
Additional Location(s): US-MN-Minnetonka; US-MA-Marlborough

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

The Principal Design Quality Engineer will support the Valencia Technologies Integration project with a focus on New Product Development. This role is responsible for leading Design Assurance activities throughout the product development lifecycle, ensuring products and processes remain safe, effective, high quality, and compliant with Boston Scientific and global regulatory requirements.

Work Mode

At Boston Scientific, we value collaboration and synergy. This role follows a hybrid work mode requiring employees to work onsite at least three days per week. This position is based in Minnetonka, MN or Marlborough, MA.

Relocation Assistance

Relocation assistance is available for this position.

Visa Sponsorship

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

Key Responsibilities

* Serve as the quality representative within cross-functional development teams, influencing project strategy, driving compliance to Design Control and Risk Management requirements, and ensuring alignment with regulatory and business objectives.

* Lead Design Assurance activities throughout product development for an active implantable technology.

* Apply sound, systematic problem-solving methodologies to identify, prioritize, communicate, and resolve quality-related issues.

* Author and maintain Design History File (DHF) documentation, including design inputs/outputs, technical rationales, verification/validation documentation, and risk management deliverables in compliance with internal and external requirements.

* Lead and support product risk management activities throughout the product lifecycle, including hazard analysis, fault tree analysis, FMEA, usability risk assessments, and post-market risk evaluation.

* Partner with R&D, Manufacturing, Regulatory, and other cross-functional teams to establish and implement Design Controls based on Risk Management, customer needs, and manufacturing inputs.

* Support verification, validation, and usability testing activities to ensure products meet internal requirements, regulatory expectations, and customer needs.

* Demonstrate strong working knowledge and application of validation methodologies, statistical techniques, and quality engineering principles.

* Collaborate effectively within a mixed onsite and remote working environment.

Required Qualifications

* Bachelor's degree in Mechanical Engineering, Electrical Engineering, Biomedical Engineering, or related technical discipline.

* Minimum of 7+ years of experience in Design Assurance, Quality Engineering, New Product Development, or related medical device/regulated industry experience.

* Strong understanding of FDA Quality System Regulation (21 CFR Part 820), ISO 13485, ISO 14971, and Design Control requirements for medical devices.

* Demonstrated experience applying Quality Engineering tools and methodologies.

* Strong verbal and written communication skills with the ability to influence across functions and levels.

* Demonstrated experience authoring and reviewing detailed technical documentation.

* Self-motivated with strong problem-solving skills and a bias for action.

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

Preferred Qualifications

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

* Experience supporting acquisition integration and quality system harmonization activities.

* Experience supporting software development lifecycle activities in accordance with IEC 62304.

* Experience facilitating structured problem-solving methodologies and risk-based…