Principal Design Quality Engineer - Urology

Boston Scientific • Maple Grove, MA

5d • Hybrid

About The Position

This is a unique and exciting opportunity for an experienced Principal Design Quality Engineer to support a high visibility sustaining/NPD team located in MN or MA. The position will require you to utilize extensive quality knowledge and technical leadership skills to help lead and execute design quality activities, in compliance with BSC design controls, and related QMS deliverables. You will work in a highly collaborative environment, with a team of quality engineers focused on Prosthetic Urology products. This role follows a hybrid work model requiring employees to work onsite at least three (3) days per week. This position is based in Minnesota (MN) or Marlborough, Massachusetts (MA).

Requirements

• 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.
• 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.

Nice To Haves

• Strong verbal and written communication skills with the ability to influence across functions and levels.
• Project Management experience supporting new product development as well as sustaining quality teams.
• Tools experience with Windchill, eCAPA, Cognition Cockpit
• Experience facilitating /supporting product usability engineering evaluation per ISO 62366
• Experience supporting regulatory inspections and external audits.
• Adaptable and effective collaborator in both team-based and self-directed environments.
• Proven ability to influence without authority
• Boston Scientific experience

Responsibilities

• Serve as the Design Quality lead within a cross-functional development/sustaining team, ensuring compliance to Design Control and Risk Management requirements and alignment with subsystem and system-level objectives.
• Lead Design Assurance activities for throughout the product lifecycle, ensuring system/subsystem requirements, interfaces, traceability, verification, validation, and risk controls are appropriately defined, reviewed, and maintained.
• Author, review, and maintain Design History File (DHF) documentation including design inputs/outputs, interface definitions, technical rationales, verification/validation documentation, product useability evaluation and risk management deliverables in compliance with internal and external requirements.
• Lead and support subsystem and product risk management activities throughout the product lifecycle, including hazard analysis, fault tree analysis, FMEA, usability risk assessments, and post-market risk evaluation.
• Lead/support product field performance analysis ensuring closed loop alignment with sustaining projects.
• Apply sound, systematic problem-solving methodologies to identify, prioritize, communicate, and resolve subsystem quality-related issues. while collaborating effectively within a mixed onsite and remote working environment.
• Partner with R&D, Systems, Manufacturing, Regulatory, and other cross-functional teams to establish and implement Design Controls based on Risk Management, customer needs, interface requirements, and manufacturing inputs.

Benefits

• Relocation assistance is not 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Principal