Description for Senior New Product Development Engineer:
The Sr. NPD Engineer will primarily be responsible for new product from initial product development through commercialization for a rapidly growing medical device firm. Responsibilities include the identification, development, and implementation of strategic initiatives, technologies, and functional excellence. Serves as oversight manager with Contract Manufacturers to ensure new products commercialization for new and existing medical device product lines.
Responsibilities for Sr. NPD Engineer:
- Identifies future technology and intellectual property critical to future business growth and drives implementation.
- Evaluate and introduce new technology and apply advanced scientific and engineering analysis to applications in development, design, and manufacturing while assuring incorporation of knowledge of current regulations, guidance documents and competitive environment into decisions and strategy.
- Responsible for examining and making recommendations for engineering and re-engineering of products and procedures.
- Performs new products cost analysis (cost-up pricing) and supports price negotiations.
- Serves as intermediary between senior management and Contract Manufacturer concerning product design and tooling to ensure efficient production methods.
- Serves as intermediary with Contract Manufacturer on other management issues as required
Requirements for Sr. NPD Engineer:
- Bachelor’s Degree in Engineering or Science with at least 10 years’ experience in engineering design and commercialization within medical device or related regulated industries.
- Knowledge of elastomer and plastic component materials
- Knowledge of medical device product design, Patents review, and Patents claims development.
- Experience with medical device and combination products and ISO 13485 design process, risk analysis, and FDA regulations.
- Familiar with statistical and process control methods to estimate future design and manufacturing capabilities.
- Strong project management and organization skills.
- Ability to work effectively in a fast-paced and small team environment
- Work requires professional written and verbal communication and interpersonal skills. Ability to interact and communicate at all levels and work with a wide range of constituencies.
- Computer literacy required (Microsoft Excel, Microsoft Project, CAD modeling software, MiniTab/Tableau).
- Ability to travel up to 20% when necessary, including international travel. Valid US Passport required.