Medical Device - NPI Engineer - Hopkinton, MA

The NPI Engineer will be vital in designing and developing new medical devices. Key responsibilities include creating assembly and test fixtures, assisting with validation studies, and optimizing processes. The engineer will ensure compliance with industry standards, contribute to manufacturing instructions, and provide training on assembly processes. The role also involves collaborating with cross-functional teams, troubleshooting complex issues, and understanding materials science relevant to medical devices.

Client Details

My client provides advanced manufacturing solutions for the medical device industry. They specialize in precision machining and laser processing to support the development of innovative medical products.

Description

Responsibilities:

• Designs assembly and test fixtures independently, implementing Design for Assembly (DFA) improvements for complex medical device assemblies.
• Assists in the execution of validation and qualification studies for medical device assemblies, ensuring compliance with regulatory standards.
• Identifies and implements line balancing and process optimization activities with minimal oversight to enhance production efficiency.
• Provides effective training on medical device assembly processes and formats Manufacturing Process Instructions according to best practices.
• Works independently to solve complex problems, leveraging input from senior colleagues as needed, while adhering to Design Controls and Quality SOPs.
• Demonstrates a strong understanding of ISO 13485, participating in audits and guiding junior engineers on compliance matters.
• Authors proposals and project timelines with guidance and participates in client calls as a secondary technical resource, effectively communicating customer needs.
• Maintains a growth mindset by actively seeking feedback, demonstrating leadership through mentorship, and adapting positively to changing priorities.

Profile

Ideal Candidate:

• 3+ years of experience in medical device design and development.
• Proficient in Microsoft Office (Teams, Excel, PowerPoint, Outlook).
• Familiar with ISO 13485 and 21 CFR regulations.
• Basic skills in SolidWorks.
• Understanding of materials science and properties of medical device materials.

Job Offer

What's To Offer:

• Competitive salary based on knowledge and experience.
• Comprehensive benefits package available.
• Includes medical, dental, and vision coverage.
• Life insurance offered as part of the benefits.
• 401(k) retirement plan available.
• Paid holidays included in the benefits package.

MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.