Manufacturing Engineer - Medical Devices

About the role

Riverpoint Medical is looking for a Manufacturing Engineer who evaluates manufacturing processes by researching and applying knowledge of product design, fabrication, assembly, tooling and materials, working with equipment vendors and operators. The engineer designs, integrates and improves manufacturing systems and processes, and troubleshoots product problems involving design, materials or processes.

Key responsibilities

• Support the manufacturing function of new product development, including fixturing design, work instruction development and production training and support.
• Create, maintain and improve manufacturing process and assembly documentation to ensure consistent production and quality performance and meet quality system requirements.
• Act as a key member of new product introduction teams, giving feedback to Development Engineers on product manufacturability.
• Lead root cause analysis sessions for problems in the new product development process.
• Design jigs and fixtures for assembly cells, sterilization, QA and final product packaging.
• Plan, coordinate and direct new production capacity initiatives, including production area and cell layout planning.
• Coordinate and support QA compliance with ISO 13485, ISO 14644, safety, environmental standards and company procedures.
• Assist in complaint investigations, NCRs and CAPA activities.
• Collaborate with key customers in product development.

Required profile

• Bachelor's degree in Manufacturing, Industrial or Mechanical Engineering or an equivalent field, or equivalent work experience.
• 0-3 years of experience in medical device development and manufacturing in an ISO-regulated, high-mix environment; FDA-regulated experience is highly desirable.
• Ability to work in a cleanroom, gown up, lift 35 lbs and stand for long periods.

Required skills

• Intermediate to advanced SolidWorks, Microsoft Word and Excel; Excel VBA, Microsoft Access or other database programming is desirable.
• Lean initiatives and automation experience.
• Desirable: DFM, Gage R&R and DoE experience, technical writing skills.