Process Engineer

Elephas • Madison, WI

4d • Onsite

About The Position

Elephas, a Madison, WI-based biotechnology start-up company, is seeking a highly motivated and creative Process Engineer. Applicants should be comfortable in a fast-paced and highly collaborative environment. The successful candidate will have hands-on experience executing verification and validation activities within a structured product development process.

Requirements

• Bachelor's degree in life sciences, engineering, biotechnology, or a related field
• 2-3 years of relevant industry experience
• Experience working in an FDA (Class II/III) and/or ISO (13485) engineering environment
• Solid understanding of design control processes and quality management systems
• Strong analytical and problem-solving skills with a detail-oriented approach to documentation
• Experience managing or working with engineering tools and software such as 3D printers, CNC, and CAD software.

Responsibilities

• Draft and maintain verification and validation (V&V) documentation for instrumentation and manufacturing processes
• Execute verification and validation protocols for instruments and consumables, and summarize results in formal reports.
• Identify, document, and implement process improvements in collaboration with Manufacturing and Quality Control teams
• Support design control activities including the creation and review of risk management documents, test methods, and acceptance criteria
• Collaborate with cross-functional teams to ensure smooth transfer of processes from development to manufacturing
• Assist in the investigation and resolution of non-conformances, CAPAs, and process deviations
• Work in close collaboration with other team members to drive innovation

Benefits

• paid time off
• health insurance
• life insurance
• flexible spending accounts
• a 401(k) plan
• stock options

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level