Engr 1, Product Development

Job Description:
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).
• 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.
• 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.