SciPro
Key Responsibilities
- Develop and document detailed work instructions and assembly procedures from design specifications.
- Train production operators and ensure adherence to process standards.
- Design, build, and validate fixtures, tools, and gauges for assembly and measurement.
- Plan and optimize manufacturing layouts, workflows, and equipment utilization to improve efficiency.
- Oversee equipment safety, maintenance, and preventive repair programs.
- Monitor process output, scrap, and yield; analyze and resolve production issues.
- Lead root cause analysis and pFMEA for recurring or critical issues.
- Collaborate with R&D and NPI teams on new product introductions and process validations (DOE, capability studies).
- Support continuous improvement initiatives focused on yield, cycle time, and cost reduction.
- Maintain compliance with ISO 13485, ISO 14971, and FDA QSR standards.
- Support plant safety initiatives and complete assigned corrective actions.
Qualifications
- Education: BS in Mechanical, Manufacturing, Industrial, or Electrical Engineering (or related).
- Experience: 5–7 years in process development and production support, ideally in the medical device industry.
- Skills:
- Proficiency in reading technical drawings and schematics; working knowledge of GD&T.
- Strong mechanical/electrical aptitude and understanding of machinery principles.
- Competency in statistical analysis (Minitab preferred).
- Skilled in Microsoft Office (Word, Excel, PowerPoint, Visio).