Engr 1, Product Development

The Product Development Engineer executes specific and general assignments or projects that provide innovative, functional, and cost-effective solutions to support product development and commercialization in a team-based environment. The PD Engineer is responsible for the tactical execution of product development deliverables while adhering to established quality, design control processes, and good engineering practices.

Responsibilities The PD Engineer:

• 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.

Requirements

• Education: BS degree in Engineering (Mechanical or Biomedical preferred).
• 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).
• 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).
• Experience with statistical techniques and technical writing beyond templated IQ/OQ/PQ documents.
• Process excellence training or certification (e.g., LSS Green Belt) is highly desired.
• Experience working in a fast-paced, cross-functional environment.

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).
• Demonstrates personal leadership and a bias for action to drive results.