Senior Product Development Engineer

This position will report to the Vice President of Research and Development

Responsibilities

Maintenance of existing products / new product development

Identifies feature enhancements and functional requirements and coordinates the necessary hardware/software changes necessary to add features and functionality to products.

Generates required documentation such as specifications, test plans, test results, and analysis.

Performs the test plans and analysis to create the test results, including the statistical analysis to ensure changes have the expected result.

Coordinates with external testing labs, for example, biocompatibility and electrical safety.

Signal processing algorithm design

Determines proper optimization targets.

Using existing datasets, performs high-dimensional optimization searches to maximize the target.

Performs verification testing of new algorithms.

Helps implement new algorithms into our products.

Clinical trials for detecting disease targets

Maintains an awareness of current clinical issues by reading relevant publications and attending clinical meetings.

Establishes relationships with key thought leaders in relevant areas.

Proposes measurements to be taken during clinical trials.

Analyzes trial results, which can feed back into updating signal processing algorithms and updated/new products.

Publishes results.

Assists in the sales and marketing process

Responds to complex customer support issues.

Aids in the development of marketing literature, especially focused on clinical applications of LKC products.

Supports the LKC quality & regulatory system

Assures that work meet US and outside US regulatory requirements.

Assures that standard operating procedures are followed.

Participates in risk management process.

Qualifications

Degree in engineering, science, or mathematics

Competent near the boundaries among these disciplines

6+ years experience

Experience in medical device industry is a plus

Familiarity with electromechanical devices is a plus

Self-assessment test

A successful candidate will score at least 50% on this test, without external resources (closed-book test):

Maintenance of existing products / new product development

Suppose you are making a new version of a product that measures something. Because of noise, there is always some variability in the measurements. How can you tell if the new version is at least as good as the original version? Did you come up with at least two measures of "at least as good"?

Signal processing

What do DFT and DWT stand for? When would one prefer to use a DFT vs. a DWT?

Clinical trials

Have you ever published a paper? Have you ever presented a paper/poster at a conference?

Quality

What are the standards ISO 14971 and ISO 13485? Why sometimes do you see “EN” in front of a standard, such as EN ISO 13485?