SPECTRAFORCE · 8 hours ago
Manufacturing Engineer II
Draper, UT
Contract
Onsite
Entry, Mid Level
$38/hr - $44/hr
2+ years expSPECTRAFOR is seeking a Manufacturing Engineer II to optimize manufacturing processes and improve efficiency. The role involves developing experiments, resolving compliance issues, and collaborating with cross-functional teams to ensure successful project outcomes.
ConsultingCRMInformation TechnologyLegal
Hiring Manager
Lakshay Kumar
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
Developing moderately complex experiments and tests (including 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 customer’s expectations, using project management tools (e.g., Project Plan, Risk Analysis, etc.)
Overseeing manufacturing support tasks; giving instruction to technicians on conducting tests; training technicians and providing feedback; and coordinating technician work
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 Scientific field with 2 years of previously related industry experience OR Master's degree in Engineering or Scientific field Required
Preferred
Good computer skills in usage of MS Office Suite including MS Project; CAD experience preferred (if applicable)
Good documentation, communication (e.g., written and verbal) and interpersonal relationship skills including consultative and relationship management skills
Strong Organizations skills with the ability to manage complex projects/tasks
Good adaptability in changing projects, directions, and priorities
Good time management skills to ensure timely completion of tasks
Ability to drive tasks with minimal supervision; self-starter
Basic understanding of statistical techniques
Previous experience working with lab/industrial equipment required preferred (if applicable)
Solid understanding and knowledge of principles, theories, and concepts relevant to Engineering
Solid problem-solving, organizational, analytical and critical thinking skills
Solid understanding of processes and equipment used in assigned work
Knowledge of and adherence to client's Environmental Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturing
Knowledge of applicable FDA regulations for medical device industry
Strict attention to detail
Ability to interact professionally with all organizational levels
Ability to manage competing priorities in a fast-paced environment
Must be able to work in a team environment, including the ability to manage vendors and project stakeholders
Ability to build productive internal/external working relationships
Understanding of Phase-gate product development
Medical device or regulated industry experience
Understanding of design requirements documentation, risk management plans, inspection criteria, test method development and validation activities
Cleanroom environment experience
Knowledge of manufacturing line design
Knowledge of process creation and process improvement
Knowledge of process and design transfer activities
Understanding/knowledge of Design for Manufacturing (DFM) principles
Company
SPECTRAFORCE
Welcome to SPECTRAFORCE, your gateway to NEWJOBPHORIA™! Established in 2004, SPECTRAFORCE is now one of the largest and fastest growing U.S.
1001-5000 employees
H1B Sponsorship
SPECTRAFORCE 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 (3)
2024 (6)
2023 (1)
2022 (6)
2021 (8)
2020 (7)
Funding
Current Stage
Late StageCompany data provided by crunchbase