- Assesses process capabilities, prioritizes process improvement opportunities, and innovates and implements process improvements on multiple and moderately complex processes.
- Applies technical knowledge to innovate, design, and develop processes, procedures, tooling and/or automation.
- Executes the functional deliverables associated with the PDP/TDP, Project Management, and Quality Systems.
- Prepares and presents technical data and recommendations at technical reviews.
- Writes validation protocols and reports applicable to new processes.
- Ensures proper documentation is completed to meet quality systems requirements. (e.g., BOM’s, Routers, FMEA’s, etc.)
- Oversees development builds associated with the project using special work requests.
- Develops qualified production lines.
- Provides Design for Manufacturability (DFM) input to the engineering print package.
- Contributes ideas to or generates Intellectual Property submissions.
- May serve as a core team lead or extended team member on new development projects.
- Possibly supervise and/or mentor engineers with the team.
Bachelor’s degree in Engineering or related field education with 3-5 years or more of experience in the Regulatory industry.
REQUIREMENTS & SKILLS
Ultimate Solutions Corp is an equal opportunity employer.
- Demonstrated use of DFSS tools (DOE, problem solving)
- Minimum of 5+ years of demonstrated process development / improvement activities.
- Demonstrated field experience with Vision Systems.
- Experience working with silicone and/or medical adhesives
- Highly motivated individual that can independently drive deliverables to completion through collaboration among team members.
- Demonstrated ability to develop and drive innovative solutions into processes and products.
- Medical Device Design experience; new product development
- Process Development; equipment validations and process characterization and validation experience
- Demonstrated cross functional teamwork in technically demanding environment
- Demonstrated ability to develop processes from concept to production
- Open to occasional travel
- GMP & ISO knowledge, understanding and experience
- Proficient in MS Word, PowerPoint, Excel, and Project
- Effective interactions in a team environment
- Team player, self-starter, persistent, tactful, and persuasive
- Good organizational skills, detail-oriented & accurate, analytical skills
- Effective verbal and written communication skills (writing and presentations)
- Fully Bilingual (English and Spanish)
- Able to work with minimum or no supervision