Acts as the liaison between development and operations.
Advocates for the process to ensure they are repeatable and can capably produce product that meets the design requirements.
Prepares and presents detailed plans necessary to complete assigned projects.
Develops schedule milestones, coordinates resources, facility and equipment for assigned projects.
Assists in improving the system of production controls, standard operating procedures, safety, quality control and training.
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.
Prepares justification for capital expenditures.
Aid in production transfers from R&D to manufacturing.
Performs other related duties as assigned by management.
Required Qualifications
Bachelor’s degree in engineering or related field
5+ years related experience in medical device industry with a heavy focus on product or process development of Active Implantable Devices. Strongly preferred experience in Neuromodulation Devices (IPGs or Leads). Experience with pacemakers, cardiac monitors, brain computer interface, etc. also considered
Extensive experience with process validations for laser welding, header attachment, and internal moisture (bake) and Test Method Validation for Helium Leak Testing
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 $105,000–$135,000.
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.
