Engr 1, Product Development

Summary

Katalyst CRO is a company focused on product development and commercialization. The Product Development Engineer executes assignments to provide innovative solutions and is responsible for the tactical execution of product development deliverables in a team-based environment.

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
• 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

Skills

• BS degree in Engineering
• Ability to adapt to shifting priorities, organize, and self-manage assigned work in a fast-paced environment
• Strong problem-solving skills relevant to the role
• Comfortable with ambiguity and able to make progress despite uncertainty
• Ability to proactively anticipate challenges and technical risks and identify paths to overcome obstacles in a compliant manner
• Proficient verbal and written communication skills
• Effective interpersonal skills to assist the advancement and success of cross-functional teams
• Proficient in applying statistical principles to analyze engineering results (e.g., capability analysis, normality, acceptance sampling, DoE)
• 1–2 years of product engineering and/or pharmaceutical development experience, with an emphasis on scaling from pilot to commercial production in a pharmaceutical environment
• 1–2 years of experience working in an FDA-regulated environment (21CFR211, 21CFR820, ISO13485)
• Experience with statistical techniques and technical writing beyond templated IQ/OQ/PQ documents
• Experience working in a fast-paced, cross-functional environment
• Mechanical or Biomedical preferred
• Process excellence training or certification (e.g., LSS Green Belt) is highly desired
• 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)

Qualifications

Must Haves

• BS degree in Engineering
• Ability to adapt to shifting priorities, organize, and self-manage assigned work in a fast-paced environment
• Strong problem-solving skills relevant to the role
• Comfortable with ambiguity and able to make progress despite uncertainty
• Ability to proactively anticipate challenges and technical risks and identify paths to overcome obstacles in a compliant manner
• Proficient verbal and written communication skills
• Effective interpersonal skills to assist the advancement and success of cross-functional teams
• Proficient in applying statistical principles to analyze engineering results (e.g., capability analysis, normality, acceptance sampling, DoE)
• 1–2 years of product engineering and/or pharmaceutical development experience, with an emphasis on scaling from pilot to commercial production in a pharmaceutical environment
• 1–2 years of experience working in an FDA-regulated environment (21CFR211, 21CFR820, ISO13485)
• Experience with statistical techniques and technical writing beyond templated IQ/OQ/PQ documents
• Experience working in a fast-paced, cross-functional environment

Nice to Haves

• Mechanical or Biomedical preferred
• Process excellence training or certification (e.g., LSS Green Belt) is highly desired
• 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)