Engr 1, Product Development

Responsibilities

• Supports the development of new products by applying engineering fundamentals and concepts to advance product development deliverables within the functional area.
• Supports installation and qualification of R&D equipment.
• Performs data analysis and writes technical reports based on product development activities.
• Supports the purchasing process of materials, equipment, and testing consumables.
• Develops and validates test methods for raw materials and in-process inspections (e.g., Gage R&R).
• Ensures compliance with Design Control process requirements throughout the product lifecycle.
• Supports Design Control process activities such as the creation and maintenance of Design History Files (DHF) and risk management (DFMEA) documentation.
• Supports the development of Device Master Record (DMR) documentation, including raw material specifications, component specifications, test methods, and manufacturing instructions.
• Counsults and conducts engineering testing, including performance, reliability, and usability assessments.
• Participates in design reviews, root cause analysis, and failure investigations.
• Assists in technology transfer and process validation activities for new product introductions.
• Ensures compliance with THE CLIENT quality policies, procedures, and practices, as well as all applicable local, state, federal, and THE CLIENT safety regulations.

Requirements

• Education: BS degree in Engineering (Mechanical or Biomedical preferred).
• Experience: 12 years of product engineering and/or pharmaceutical development experience, with an emphasis on scaling from pilot to commercial production in a pharmaceutical environment. 12 years of experience working in an FDA-regulated environment (21CFR211, 21CFR820, ISO13485).
• Skills: Proficient in applying statistical principles to analyze engineering results (e.g., capability analysis, normality, acceptance sampling, DoE).
• Additional Skills: Familiarity with FDA regulations for medical devices, drug products, and combination products is a plus. Skilled in root cause analysis techniques (e.g., 5 Whys, Ishikawa). Experienced with computer-assisted statistical tools (e.g., Minitab, Excel).