Senior Design Quality Engineer

bostonscientific • Valencia, MA

10h • $89,200 - $169,500 • Hybrid

About The Position

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.

Requirements

• 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.
• Strong presentation & communication skills.
• Computer skills required including Excel, Word, and PowerPoint.
• Potential global and US travel up to 40%.

Nice To Haves

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

Responsibilities

• 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

What This Job Offers

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