Prepares and maintains detailed layouts of buildings and equipment
Coordinates the manufacturing launch of new/revised products including establishing goals, training team members, and evaluating results
Designs, develops and tests as well as sources various tools, machinery and equipment for recommended manufacturing methods while providing ROI analysis
Performs product/process analysis for production and quality metrics
Write engineering change orders to process changes to manufacturing documents, drawing, and Bill of Materials
Support company finance, accounting, human resources, quality, regulatory, and clinical departments as necessary to ensure compliance with requirements
Recommend, support and implement improvements, modifications, or additions that will improve work processes
Take the lead in analyzing the need for new process development and to meet company needs including specifying, ordering, installing and validating new equipment or processes
Prepare justification for capital expenditures
Aid in production transfers from R&D to manufacturing
Propose potential new manufacturing technologies, including automation and new equipment
Contribute to the definition, development and implementation of LEAN manufacturing initiatives
Required Qualifications
Bachelor’s degree in engineering or related field
10+ years related experience in medical device industry with a focus in Process Development
Demonstrated ability to independently develop medical device manufacturing processes from concept to production.
Experience with medical device Design For Manufacturing, design control, quality systems and product development phases
Demonstrated ability to implement change in a way that positively impacts overall department and company performance
Must be able to handle multiple projects simultaneously
Must excel at working in a team environment with a high level of people/interpersonal skills and demonstrated ability to cross functionally drive results
Experience using influence to affect project and organizational success
Experience with programs including SolidWorks and/or Mastercam
MS Office Proficiency
Ability to handle and be trusted with confidential and/or sensitive information
Physical Demands
Prolonged periods of sitting at a desk and working on a computer
Must be able to lift up to 25 pounds at times
Must have excellent hand-eye coordination
Ability to differentiate between colored wires, tabs, and electronic components
Must wear gown, gloves, and ear protection if applicable
Compensation
The compensation for this role is competitive and will be based on experience and qualifications. The anticipated range is $118,000K-$186,000.
Our company policy is that we are unable to provide visa sponsorship. Candidates must already be legally authorized to work in the United States without the need for sponsorship now or in the future.