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Sr. Process Development Engineer
2 months ago
Job Type
Full-time
Description
Job Summary
The Senior Process Development Engineer works cross-functionally to lead process development of complex medical devices and ensures effective transfer of designs into production.
Essential Functions
- Works independently to drive project completion by developing the processes used to manufacture component, sub-assemblies, and FG devices.
- Provides leadership and coaches less experienced engineers and technicians.
- Acts as the liaison between development and operations.
- Advocates for the process to ensure they are repeatable and the process can capability produce product that meets the design requirements.
- Prepares and presents detailed plans necessary to complete assigned projects.
- Develops schedule milestones, coordinates manpower, 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.
- Performs other related duties as assigned by management.
Education, Experience, Required Skills
- Bachelor's degree in related field (equivalent work experience may be considered)
- 5+ years related experience as an individual contributor, with strong strategic focus in the areas of Product and 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 with programs including SolidWorks and/or Mastercam
- MS Office Proficiency
- 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.
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