We are seeking a Senior Engineer to work on a team at our client site in Draper, Utah. The position is W2 hourly with Roth Staffing, with all work being conducted at the client site. Prior medical device manufacturing experience is preferred. No 3rd party candidates will be considered.

• Sr engineer is expected to lead/co-lead every project
• Experience leading programs in the past as technical lead
• Strong collaboration and communication
• Process and design
• DFM principals
• Top Skills
• Line Design
• Fixture Design and Build - equipment, understanding, vetting out, development, process development
• Strong documentation skills
• Development, creations of document protocols, design/validation/etc
• Soft Skills
• 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
• Will be involved in a top/high visibility project
• Class II/III Medical Device experience would be a major plus
• Bachelors degree in engineer/scientific

Senior Engineer, Manufacturing

How you will make an impact:

• 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.

What you'll need (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.

What else we look for (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

All qualified applicants will receive consideration for employment without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, medical condition, genetic information, pregnancy, or military or veteran status. We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, including the California Fair Chance Act, City of Los Angeles' Fair Chance Initiative for Hiring Ordinance, and Los Angeles County Fair Chance Ordinance.