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Product Development Engineer
5 months ago
At NAGL MedTech™, we offer a wide array of roles to support medical device companies of any size at any stage. Our model utilizes a fractional but best-in-class workforce approach to Medical Device Development. The result is optimal talent deployed when the project requires it, which improves time to market without the risk of heavy fixed costs. NAGL MedTech™ associates are trained to our FDA and ISO compliant Quality System and Business Systems, or our teams can flex into the client’s systems if that is more advantageous.
GENERAL
The Product Development Engineer assists in and potentially leads the conception, design and development of new products and their processes using design and development systems in accordance with FDA and international regulations. The primary responsibility of the Product Development Engineer (“PDE”) is to create a product design that fulfills the client's strategic goals while integrating the needs of marketing, sales and manufacturing departments. The PDE may oversee research and design teams, lead testing procedures and draft specifications for manufacturing. The PDE also may direct the creation of models or samples and fine-tune designs until they are ready for production.
ESSENTIAL FUNCTIONS
- Designs, develops and prototypes new products in accordance with company Project Lifecycle Management (PLM) requirements
- Evaluates, documents, and implements potential design and process changes to improve product performance, manufacturability, safety or cost consistent with GMP or company PLM process
- Oversees testing and theoretical analysis of products to determine product safety and efficacy
- Evaluates the feasibility of selected concepts to meet functional, clinical and customer needs and provides input on the design, manufacturing process, quality needs and testing during the development process; develops new design and manufacturing processes as needed.
- Makes prototype products / fixtures either by direct use of machining equipment or by directing outside suppliers with appropriate drawings.
- Generates test protocols, test reports, timelines and cost estimates for development tasks.
- Builds test equipment, conducts testing of product, and analyzes data as needed.
- Follows approved procedures such as GOPs, OPSs, QLPs, etc. for activities conducted and updates or generates new procedures as needed.
- Maintains strong working knowledge of U.S. Quality System Regulations and ISO 13485 and helps ensure company-wide compliance.
- Assesses reliability, safety, performance and risk of new designs and methodologies and insures individual and group safety when conducting all activities.
- Maintains effective communications with supervisor and peers in project activities.
- As necessary, suggests strategic direction for specific projects and provides input into the creation or modification of product specifications in alignment with client requirements.
- Supports manufacturing activities, as necessary.
DESIRED KNOWLEDGE, SKILLS AND ABILITIES
- A minimum of a bachelor’s degree in Engineering and a minimum of 2 years’ experience in a medical device R&D environment OR an equivalent combination of education and experience.
- Knowledge of manufacturing processes, materials and quality assurance protocols.
