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.
Required Competencies / Skills:
- 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.