Ledgent Technology · 11 hours ago
Sr Engineer (Manufacturing/Med Device)
Draper, UT
Contract
Onsite
Mid, Senior Level
4+ years expLedgent Technology is seeking a Senior Engineer to work on a team at their client site in Draper, Utah. The role involves leading projects in medical device manufacturing, optimizing processes, and ensuring compliance with industry standards.
Staffing & Recruiting
Hiring Manager
Melanie Delaney
Responsibilities
Identifying and ensuring implementation of opportunities to optimize/improve manufacturing processes including using engineering methods (e.g., SIX Sigma and LEAN methods) employing technical design skills to re-design/design of and ensuring equipment, tools, fixtures, etc. are up to standards
Developing 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 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
Leading and 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 4 - 10 years of previously related industry experience OR Master's degree in Engineering or Scientific field with 3 - 7 years of previously related experience required
Experience leading programs in the past as technical lead
Strong collaboration and communication
Process and design
DFM principals
Line Design
Fixture Design and Build - equipment, understanding, vetting out, development, process development
Strong documentation skills
Development, creations of document protocols, design/validation/etc
Strong Leadership (must have)
Ability to communicate up and down various levels
Understanding - flexibility and adaptability to understand that projects need to redirect if needed
Fast paced environment
Class II/III Medical Device experience would be a major plus
Preferred
Proven expertise in usage of MS Office Suite including MS Project; CAD experience preferred
Strong 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 preferred
Substantial understanding and knowledge of principles, theories, and concepts relevant to Engineering
Strong problem-solving, organizational, analytical and critical thinking skills
Substantial understanding of processes and equipment used in assigned work
Good leadership skills and ability to influence change
Knowledge of and adherence to Edwards 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 inter-departmental collaboration
Company
Ledgent Technology
Ledgent Technology, a business line of Roth Staffing Companies, utilizes proven processes and their robust professional network to place qualified technology professionals in contract, contract-to-hire, direct-hire roles and project teams throughout the US.
501-1000 employees
Funding
Current Stage
Late StageCompany data provided by crunchbase