Senior Design Quality Engineer

Overview

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Additional Location(s): US-MA-Marlborough;
Canada-ON-Mississauga; US-CA-Valencia; US-MN-Arden Hills; US-MN-Maple Grove

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.

The Senior Quality Systems Engineer will act as a Subject Matter Expert for the Design Controls and Risk Management spaces within acquisitions, specifically focusing on active implantable and capital equipment products. Responsibilities include product development, remediation, and distribution of acquired products. The engineer will serve as a Global Quality representative leading awareness, visibility, and communication of quality initiatives to support global quality goals, priorities, and compliance in the acquisition and integration space.

The engineer will partner with design teams across all divisions to drive and improve our acquisition design strategies, in collaboration with the global design activities sub-process stewards.

At Boston Scientific, we value collaboration and synergy. This hybrid role can be located at any BSC Design site and requires being on-site at least three days per week.

Relocation assistance is not available for this position.

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

• Develops integration strategies and approaches relating to Design Controls, Risk Management, and other areas of the Quality System as required.
• Delivers and manages completion of functional deliverables, including updates to documents, procedures, and knowledge sharing documents as required.
• Applies technical quality engineering principles and systematic problem-solving methodologies to acquisition products or sites.
• Investigates, identifies, and implements best-in-class Quality Engineering practices as requested by management.
• Demonstrated competency in design activities to support the development of products to meet or exceed internal and external requirements.
• Partnering with all upstream and downstream process owners to ensure the right linkages with the Global Risk management Process are maintained (i.e., production and process controls, material controls, post-market support).
• Maintains and enhances cross-functional team relationships within divisions, manufacturing plants, distribution centers, and global BSC network.
• Advises management on potential improvements or enhancement to quality systems and processes in the company.
• Assists in identifying and developing tools that facilitate BEST4 processes

• Bachelor's degree in Science, Health, or Engineering
• Minimum of 5 years of related work experience in the medical device regulated industry.
• Working knowledge of US and International regulations and standards applicable to BSC including 21 CFR 806 & 820, ISO 13485, ISO 14971, EUMDR, CMDR, and MDSAP.
• High energy problem solver capable of driving items to closure.
• Computer skills required including Excel, Word, and PowerPoint.
• Potential global and US travel up to 40%.

• > 3 years of experience working on acquisitions.
• > 3 years working with Active Implantable devices.
• > 3 years working with Capital Equipment.
• Experience with in BSC quality systems.
• Project Management Experience
• Experience working with functions such as Operations, Regulatory, Research and Development, Clinical, and Quality.

Requisition

Minimum Salary: $89,200

Maximum Salary: $169,500

The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) – see  – will vary based on actual location of the position and other pertinent factors considered in determining actual compensation…