Senior Design Quality Engineer - Peripheral Interventions

Boston Scientific Gruppe; Maple Grove (MN); Hybrid; USD 82,000 - 157,000; Full time

Job summary

An established industry player is seeking a Senior Design Quality Engineer to lead quality initiatives in product development for medical devices. This role offers the opportunity to work on innovative health solutions, ensuring compliance and safety throughout the product lifecycle. As a key member of a dynamic team, you will apply your expertise in design control and risk management to enhance product quality and performance. Join a forward-thinking organization dedicated to improving patient lives through cutting-edge technology and collaborative teamwork.

Qualifications

• 4+ years of experience in design quality or product development in Medtech.
• Knowledge of IEC standards and key regulatory requirements.

Responsibilities

• Ensure design implementation aligns with product intent and quality standards.
• Collaborate with teams for Risk Management documentation.

Skills

Design Control

Risk Management

Quality Standards Knowledge

Problem-Solving Methodologies

Education

Bachelor’s degree in engineering or related field

Tools

FMEA

Hazard Analysis

Job description

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Senior Design Quality Engineer - Peripheral Interventions

Onsite Location(s):

Maple Grove, MN, US, 55311

Additional Location(s): N/A

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance

At Boston Scientific, we offer opportunities to work with diverse, high-performing teams on important health industry challenges. We provide access to the latest tools, information, and training to help you advance your skills and career. We support your growth and ambitions.

About the role:
We have an exciting opportunity for a Senior Design Quality Engineer to work on product development activities for Medical Electrical Equipment within Boston Scientific’s Interventional Oncology, Embolization, and Vascular portfolios. This role can be hybrid or on-site and involves cross-functional collaboration to ensure safety, quality, and compliance of a System. The Senior Design Quality Engineer will serve as the quality lead throughout the product lifecycle, including design, development, verification, validation, and maintenance.

Your responsibilities include:

• Representing the voice of quality on the product development team to ensure design implementation aligns with product intent, quality standards, and business objectives.
• Developing and maintaining understanding of the product/therapy space, including clinical applications, to effectively integrate this knowledge with quality management system requirements.
• Applying Design Control and Risk Management processes throughout product development, providing quality and compliance input for project decisions.
• Creating, executing, and documenting System Design Validation & Verification activities, including protocols, test cases, reports, and issue resolution.
• Collaborating with cross-functional teams to support Risk Management documentation such as Hazard Analysis, Task Analysis, FMEA, and Software FMEA.
• Applying systematic problem-solving methodologies to identify, prioritize, communicate, and resolve quality issues.
• Providing quality expertise and supporting audits as needed.
• Advising management on potential improvements to quality systems, processes, and products.

What we’re looking for in you:

Required Qualifications:

• Bachelor’s degree in engineering, physics, math, or related science discipline, or equivalent.
• At least 4 years of experience in design quality, system testing, R&D, or product development in the Medtech or regulated industry.
• Knowledge of industry standards (e.g., IEC 60601, IEC 62304) in product design and development.
• Ability to navigate ambiguous situations collaboratively and innovatively.
• Understanding of key regulatory requirements including ISO 13485, ISO 14971, 21 CFR 820, and EU MDR.
• Travel approximately <10%.

Preferred Qualifications:

• Experience in Complex Systems Development or Integration Engineering.
• Experience with variable and attribute test method generation and validation.
• Familiarity with risk management tools like hazard analysis and FMEA.
• Ability to collaborate within a global, matrixed team.
• Experience with Class III Medical Devices.

Additional Information:

Requisition ID: 605515

Salary Range: $82,600 - $156,900

Our compensation packages vary based on location, experience, education, and organizational needs. Boston Scientific is committed to diversity and inclusion and is an equal opportunity employer. We require certain roles, especially in healthcare, to verify COVID-19 vaccination and conduct drug testing for safety-sensitive positions.

We are dedicated to advancing science and improving patient lives through innovative medical solutions. Join us if you’re a problem-solver eager to make a meaningful impact worldwide!