Sunrise Systems, Inc. ยท 1 month ago
Product Test Engineer / Mechanical Engineer 1
Sunrise Systems, Inc. is a leading Medical Devices Manufacturing Company seeking a Product Test Engineer / Mechanical Engineer 1 for a 12-month contract. The primary role involves executing testing as scoped within individual projects, including sample management, protocol generation, and data analysis.
Information Technology & Services
Responsibilities
Conducts timely sample intake, including receipt, proper identification, storage and return shipments as needed
Conducts testing as assigned utilizing appropriate test methods, protocols specifications and equipment (includes product and/or equipment testing), including adhering to test schedules (e.g. stability pulls, aging pulls)
Conducts data analysis as per protocol or specifications utilizing variety of data analysis tools (e.g. excel, JMP, MiniTab)
Communicate challenges, scheduling or testing conflicts and other issues to management in timely manner
Maintains inventory of lab supplies, including but not limited to; general supplies (e.g. PPE, wipes, cleaners...) and chemicals use for routine testing and/or cleaning
Conducts routine sample disposition (e.g. return to client, disposal), including coordination of hazardous waste disposal
Responsible to maintain the lab and storage areas in a clean an organized manner. Includes routine lab cleaning and housekeeping
Adheres to Client Quality Systems, including but not limited to; timely identification, and notification of potential Quality Events (e.g. OOS, Deviations, CAPA...) and the subsequent forward processing and investigation of such events
Follows established Standard Operating Procedures, makes recommendations for edits, enhancements, and/or new procedures
Reviews and may draft equipment or other lab documents (e.g. SLP, LWIs) under supervision from lab management
Reviews test results, including data analysis and draft reports
Interacts with clients to provide updates and technical overviews as needed under supervision from lab management
Reviews and may author test methods/protocols/reports under supervision from lab management
Works and communicates openly, collaboratively, and respectfully with colleagues and staff
Communicates with clients under the supervision from lab management
Qualification
Required
Associates degree with 0-2 years' experience
A combination of education and experience in laboratory services, medical device, IVD and/or pharmaceutical industry, preferably in a contract testing and/or laboratory environment will be considered
Attention to detail with the ability to multi-task in a fast-paced environment and manage changing priorities with the capacity to effectively communicate across the organization
Preferred
Knowledge of GLP, cGMPs, ISO and ASTM methodologies beneficial
Technical written/oral communication skills with working knowledge of Excel and other data analysis tools required
Benefits
ACA compliant medical coverage
Dental insurance
Vision insurance
Sick time benefits as required per State regulations
Company
Sunrise Systems, Inc.
Sunrise Systems was founded in 1990 with a clear vision to deliver world-class staffing service solutions in all labor categories, including IT consulting and solutions; all with the commitment to provide service that exceeds expectations and become the most trusted name in the industry.
H1B Sponsorship
Sunrise Systems, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2024 (2)
2020 (2)
Funding
Current Stage
Late StageCompany data provided by crunchbase