R&D Medical Device Engineer - TMV/CAD/Gage

Infotree Global Solutions; Cambridge (MA); On-site; USD 65,000 - 95,000; Full time

Job summary

Infotree Global Solutions in Cambridge, MA is seeking a candidate with 3+ years of experience in a regulated environment to support the Physical Sciences and Engineering initiatives. The role emphasizes development and lifecycle management of physical GMP test methods, validation of test systems, and translating user needs into engineering documentation.

The ideal candidate has a math/statistics background, exposure to CAD/SolidWorks, and hands-on lab experience.

Qualifications

• 3+ years of experience in a regulated field; bachelor's degree required.
• Experience with GMPs and medical device environment preferred.
• Strong fundamentals in statistics and data analysis.

Responsibilities

• Develop and manage physical GMP test methods and associated documentation (test method protocols, SOPs, training documents).
• Validate and lifecycle-manage testing equipment and systems.
• Assist with engineering studies for automated test systems installations.
• Analyze test data and report findings to stakeholders.

Skills

Regulated industry

GMP exposure

Statistics fundamentals

Test method development

CAD design

SolidWorks

Mechanical modeling

R

Python

Lab experience

Education

Bachelor's degree in Engineering or related field

Tools

SolidWorks

Gage R&R

Job description

Ideal candidate: 3 YOE in field desired with bachelors. Experience working in a regulated industry, exposure to GMPs, Medical Device experience is highly desired. Mathematical background fundamentals of statistics. Useful to have exposure to test method development, CAD design, Solidworks, mechanical modeling. Nice to have programming R and python experience. hands on technical experience useful, comfortable working within a lab.

Job Details: Position involves support of senior staff in the initiation, design, and delivery of projects, particularly for the Combination Product Operations MS&T - Physical Sciences and Engineering (PSE) organization. Responsibilities include development and lifecycle management of Physical GMP Test Methods, lifecycle management of integrated testing machines, development and validation of test methods. The successful candidate employs basic engineering skills and practices to gather user requirements and translate them into technical documentation. Assist with project definition by performing engineering studies and assessment for automated test systems installations. Perform field evaluations of existing systems and provide engineering design recommendations.

The ideal candidate enjoys tackling challenges and excels at organizing information from numerous sources to provide well-constructed deliverables. This individual has a passion for modeling, analytics, and technology. The successful candidate will be given opportunities to apply their expertise to enhance the way data is used to inform and make decisions

This may include, but is not limited to, the following:

• Collaborate with Engineers using the system to edit, develop, and run automated, experimental protocols.
• Knowledge on Equipment and Method validation principles, generation of Lifecycle Documentation such as FAT/SAT, IQ/OQ, equipment characterization protocols, Gauge Repeatability and Reproducibility studies
• Assisting Engineers to successfully develop, transfer and execute processes on the integrated platforms and equipment.
• Developing, enhancing, automating, and managing test data
• Network with manufacturing and quality organizations internal to Client
• Ensuring all tasks and responsibilities are performed according to industry-leading scientific standards & accurately documented per SOPs
• Monitoring technological developments in the field & evaluation of new technologies

Preferred Skills

• Experience working in a regulated industry, exposure to GMPs
• Excellent verbal and written communication skills to communicate project status and risks associated with integrated timelines to leadership
• Statistical analysis, and knowledge of Gage R&R,
• Knowledge of Optical measurement devices, force testers, BLE testing
• Manufacturing experience, IQ, OQ, and PQ

Preferred Traits

• Passion for proactively identifying opportunities through creative data analysis and modeling
• Intellectual curiosity with ability to learn new concepts/frameworks, algorithms, and technology rapidly as needs arise
• Ability to manage multiple, competing priorities simultaneously, experience with MS Project

Top 3 Must Have Skill Sets

• Excellent verbal and written communication skills to communicate project status and risks associated with integrated timelines to leadership
• Ability to manage multiple, competing priorities simultaneously
• Statistical analysis and knowledge of Gage R&R

Day to Day Responsibilities

• Develop and support lifecycle management of physical test methods and associated documentation (test method protocols, SOPs, training documents, etc.)
• Execute test method protocols, analyze data
• Maintain projects status and communicate with Client internal clients