Infosoft, Inc. · 20 hours ago
Manufacturing Process Engineer (Medical devices) - (W2 Only/NO C2C)
Draper, UT
Contract
Onsite
Mid Level
$45/hr - $60/hr
3+ years expInfosoft, Inc. is seeking a Manufacturing Process Engineer specializing in medical devices. The role involves optimizing manufacturing processes, ensuring compliance, and developing training materials while collaborating with cross-functional teams.
ConsultingDeliveryHuman ResourcesInformation Technology
Hiring Manager
Jack J
Responsibilities
Optimizing manufacturing processes, including using engineering methods (e.g., SIX Sigma and LEAN methods) for continuous process improvement and/or re-design/design of equipment, tools, fixtures, etc. to improve manufacturing processes, employing technical design skills
Writing and executing protocols to qualify and validate manufacturing processes; analyzing results, making recommendations, and developing reports
Analyzing and resolving moderately complex Manufacturing and Compliance issues (e.g., CAPA, non-conformances, audit observations)
Developing training and documentation materials (e.g., work instructions) for production to enable the seamless knowledge transfer of project and manufacturing processes
Establishing project plans to ensure deliverables are completed to the customer’s expectations, using project management tools (e.g., Project Plan, Risk Analysis, etc.)
Overseeing manufacturing support tasks; giving instructions to technicians on conducting tests; training technicians and providing feedback; and coordinating technicians
Collaborating across sites and cross-functional teams (R&D and commercial)
Coordinating manufacturing builds and raw material allocations
Leading process validations (IQ, OQ, PQ)
Supporting documentation for the team
Qualification
Required
A Bachelor's degree in Engineering or a scientific field with 4 years of previously related industry experience, or a Master's degree in Engineering or a scientific field with 3 years of previously related experience, is required
Medical device industry experience
Experience in manufacturing line design
Manufacturing process creation and process improvement
Experience with process validations (IQ, OQ, PQ)
CAD experience (SolidWorks or Creo preferred) and tools/fixtures design
Understanding of the Phase-gate product development
Strong documentation, communication (e.g., written and verbal), and interpersonal relationship skills, including consultative and relationship management skills
Understanding of design requirements documentation, risk management plans, inspection criteria, test method development, and validation activities
Cleanroom environment experience
Knowledge of process and design transfer activities
Understanding/knowledge of Design for Manufacturing (DFM) principles
Proven expertise in usage of MS Office Suite, including MS Project
Basic understanding of statistical techniques
Ability to drive tasks with minimal supervision; self-starter
Substantial understanding and knowledge of principles, theories, and concepts relevant to Engineering
Good leadership skills and the ability to influence change
Knowledge of and adherence to Environmental Health and Safety and Quality guidelines as they relate to the department's clean room medical device manufacturing
Knowledge of applicable FDA regulations for the medical device industry
Strict attention to detail
Company
Infosoft, Inc.
Infosoft is an HR services company focused on recruiting talent and building teams throughout the US market.
201-500 employees
H1B Sponsorship
Infosoft, 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
2025 (17)
2024 (37)
2023 (10)
2022 (14)
2021 (19)
2020 (23)
Funding
Current Stage
Growth StageCompany data provided by crunchbase