Mechanical Test Engineer - Medical Device

Infotree Global Solutions; Cambridge (MA); On-site; USD 90,000 - 130,000; Full time

Job summary

Infotree Global Solutions is seeking a candidate with 3+ years in the field and a bachelor's degree to support the design and deployment of physical GMP test methods for the Combination Product Operations MS&T - Physical Sciences and Engineering.

Responsibilities include development and lifecycle management of test methods and integrated testing equipment, with emphasis on user requirements and technical documentation.

Qualifications

• Experience in a regulated industry with GMP exposure.
• Bachelor's degree in a relevant field.
• Strong background in statistics and data analysis.
• Familiarity with test method development, CAD design, and modeling.
• Experience with medical device projects and lab work.

Responsibilities

• Support initiation, design and delivery of projects within PSE.
• Develop and lifecycle manage Physical GMP Test Methods.
• Lifecycle management of automated test systems and equipment.
• Develop, validate and document test methods and protocols.
• Perform engineering studies for automated test system installations.
• Analyze data from test protocols and prepare technical docs.

Skills

GMP experience

Medical device experience

Statistics

Test method development

CAD design

SolidWorks

Mechanical modeling

R

Python

Lab experience

Data analysis

Education

Bachelor's degree

Tools

SolidWorks

Python

R

Job description

Ideal candidate: 3 YOE in the field desired with a bachelor's. Experience working in a regulated industry, exposure to GMPs, and 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

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

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

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